經濟部中央標準局貝工消#合作社印製 190858 Λ 6 __Β6_ 五、發明説明（1 ) ♦發明背景 本發明偽關於一種自動免疫裝置及其使用方法。 免疫試驗一般之執行乃藉使用不同標記化合物如酵素 ，螢光物質例如螢光素或若丹明，發光物質如吖啶酯（ac_ ridinium ester),魯米諾（luminol)或異魯米諾（isolum -i no 1)及放射同位素如碘125,碘131,碩14或氚 來實施。使用放射性同位素如標記化合物（RIA)的放 射性免疫化驗及酵素免疫試驗使用酵素為標記化合物（E IA)為已知。在它們之中，酵素免疫試驗（E IA)已 被廣泛使用特別是在臨床測試的領域中鑑於其區分度及靈 敏度。在酵素免疫試驗（E IA),通常結合選擇對一待 定物體抗原或抗體，亦即，抗體或抗原其披測量到固相材 料而撝帶選擇抗原或抗體的固相材料被允許接觸之包含在 一樣本溶液中藉此引起一抗原-抗體反應發生在其間。酵 素標記反應或鍵結抗原或抗髏從不反應中分離，亦即，自 由酵素標記抗原或抗體。在分開後其通常稱為無束縛（B /F)分離，而標記反應物質酵素的行動被測量，因此在 樣本中的測量物體被定量測量。 因此，為了執行酵素免疫試驗（EIA)，多個非常 複雜程序，如試劑的徹小增加等，稀釋，攪拌，無束縛分 離，固相位移等皆需要。 就使用於酵素免疫試驗（E IA)的固相材料，聚乙 稀粒，磁粒子及一反應室的内壁表面是已知的。 某些改進在酵素免疫試驗上已被提出。其中之一為一 (請先閱讀背面之注意事項再填寫本頁) 裝 訂 線. 本紙張尺度边用中国@家標準（CNS)曱4規格（210x297公潑） -3 - 199658 Λ 6 Β6 經濟部中央標準局员工消#合作社印製 五、發明説明（2 ) 針對使用在酵素免疫試驗中之試劑容器的改進。曰本〖(^-ai (P) 62 — 27345說明一用於執行酵素免疫試驗 以高蚕敏度之技術，其中磁粒子被用為固巧材料而無束缚 分離藉使用一特殊容器包含此一磁粒子及一具有一永久磁 性相對於容器排列的磁分離裝置來執行。此外，日本Kok-ai ( P ) 1 —20 1 1 56說明此種技術其中使用一徹板 用來包含磁粒子及一磁分離器。日本1(〇1^丨（？）63-2 8 1 0 5 3說明一容器具有多個孔槽例如反應孔槽及樣 本孔槽等，以矩陣排列。 另一方面，用來測量一大筆樣本之一半自動測量裝置 已被發展例如示於E. Ishikawa, ''酵素免疫試驗〃中， Igaku Shoin，1 8 ◦頁到 2 ◦ 7 頁。 然而，已知，在任何已知方法及裝置中Γ執行手動測 量需花費1小時到1 8小時即使磁粒子使用為固態材料。 亦即傳統半自動裝置被使用，此時間不能充分減少由於某 些複雜程序仍舊需要。 ♦ \發明灰要 發明的一個目檫在於提供一自動裝置用於酵素免疫 試驗（EIA)或放射同位素免疫試驗（RIA),其可 分別測量一些需要不同測量處理相同及/或不同測試項， 在非常短時間中對每項。 本發明的另一目檫在於提供一免疫方法藉使用本發明 的裝置執行。 (請先閲讀背面之注意事項再填寫本頁) 裝· *1T< 線· 本紙張尺度逍用中國固家標準（CNS)甲4規格（210X297公潑） -4 - 經濟部中央標準局貝工消費合作社印製 199858 Afi A o __B6_ 五、發明說明（3) 本發明的另一目標在於提供一在自動裝置中使用之反 應儲存匣。 根據本發明，以上目標及其他目標可藉由提供一用來 測量抗原或抗體在一測量物中例如血清或人之自動免疫裝 置來完成。此裝置包含一樣本儲存部分用於儲存多個樣本 ，一試劑儲存部分用於儲存清洗及/或稀釋液，一反應儲 存匣積存器部分用於儲存多個反應儲存匣每個儲存匣最好 由塑·材料如聚苯乙烯樹脂，聚丙烯樹脂，聚氯乙烯樹脂 或玻璃所形成且一整成型成至少並列排的兩個孔槽，其第 一個孔槽用於儲存攜帶抗原或抗體固相材料而其第二値孔 槽用來儲存標記物質其為抗原或抗體標記與標記化合物， 一反應線部分用來順序移動反應儲存匣，一反應儲存匣傳 輸部分用來傳輸儲存匣從反應儲存匣積存器到一反應線起 動位置一個接一個根據一測量項，一吸引/分注傾倒部分 置於一下游位置沿反應線用來傾倒每個在樣本儲存部分中 之樣本及移動至此儲存在儲存匣的第二孔槽中之物質到儲 存匣的第一孔槽以獲得它們的混合，至少一攙拌部分用來 晃動儲存匣以攪拌混合物在第一孔槽中，至少一磁無束缚 分離器用來磁性地從在第一孔槽中之擬拌混合物的不反應 部份分離反應部分。一清洗部分用來從第一孔槽移開不反 應部分，一分注傾倒/攪拌部分用來散佈底層溶液到第一 孔槽且攪拌它，一測量部分用來光學的測量在第一孔槽中 界於底層及反應部分間之反應所産生的發光資訊，一輸出 部分用來輸出一在測量部分中獲得的測量，一配置部分提 (請先閱讀背面之注意事項再填寫本頁) 裝- 線· 本紙張尺度边用中國國家標準（CHS)甲4規格（2丨0x297公龙) -5 - 199858 Λ 6 Β6 經濟部中央標準局员工消費合作社印製 五、發明説明（4 ) 供在反應線的末端部分周圍用來配置儲存匣測完成之測量 及一控制部分用來控制上述部分的操作。 這些構成部分中可能有些在持定測量中不使用或它們 的使用順序可能改變，因為免疫試驗可能以不同過程執行 。此外，儲存匣的孔槽數目及這些孔槽的體積或深度可根 據要求而改變。已知的大體上有兩测量方法。其中之一為 稱做"一步〃方法用來測量抗原或抗體而另一値稱為、、兩 步〃方法。此一步方法包括兩變化每個皆可應用到抗原或 抗體測量。在一變化中，配體及標記抗體被同時加到固相 材料而在一無束缚分離披執行後底層被加到其上。在另一 變化稱為延遲方法中，一配體及標記抗體的混合被加到固 相材料且然後一無束缚分離被執行在底層的加入後。因此 ，在a —步"方法中，儲存匣的孔槽的數目可為兩個且一 値單無束縛级可能就足夠了。 1兩步方法"被分為抗原測量方法及抗體測量方法。 . / 在抗原測量方法中，固相材料及配體（lUand)被混合在第 一孔槽中。在清洗後，酵素標記抗體被混合一起，然後一 無束缚分離被執行後底靥被加入。在抗體測量中，抗體被 稀釋且於後與固相材料混合。在清洗後，標記記億體被加 入之後，一無束縛分離被執行而後底層被加入。在''兩步 "方法中，需要一對無束缚裝置而母儲存匣的孔槽數可為 3。 雖然儲存匣可由任何上述材料形成，鑑於成本及透光 性聚苯乙烯樹脂可能最適合。此外，儲存匣被形成在其相 本紙張尺度边用中國國家標準（CNS)甲4規格（210x297公茇） -6 ~ (請先閒讀背面之注意事項再填寫本頁) 裝- 線· 199858 Λ 6 Β 6 經濟部中央標準局员工消費合作社印製 五、發明説明（5 ) 反端具凹處或突出部以穩定其狀態在處理期間而孔槽必須 以一適合的密封膠片密封人使例如攜帶抗原或抗體之固相 材料之試劑可被穩定儲存在這些孔槽中直到它被用到時。 關於做為密封膠片方面，鋁箔，許多高分子膠片可單一或 叠合使用。在使用中，密封膠片可由一合適打破器打破。 此外，可能同時測量一樣本的兩不同項藉由在撝帶不 同抗體在儲存匣的不同孔槽中分別的儲存固相材料。另外 ,兩樣本可被同時處理藉由在攜帶相同抗體在儲存匣的不 同孔槽中儲存固相材料。在此一情形中，每値儲存匣的孔 槽數必須為四或更多。這些孔槽之一可被用為稀釋孔槽而 於其中樣本被稀釋。 較適合地儲存匣的孔槽其接收固相材料攜帶抗體必須 具有一大體積且深於其它孔槽以允許其上的反應溶液的加 入及幫助一反應的外部偵測。 使用於本發明的固相材料可為儲存匣本身的孔槽的一 内壁，顆粒或粒子。此種顆粒可為聚乙烯。至於粒子，磁 性材料的粒子或含磁性材料之粒子皆適合。特別地，鐵磁 粒子可能最適於本目的。 當固相材料為磁粒子，無束缚分離可披逹成在之包含 此種粒子之儲存匣的一孔槽中，藉應用一到其上的外磁場 。亦即，上述裝置可被應用到這些方法的任一個中藉由改 變儲存在控制部分的一記億體中的處理程式。 用於本發明的抗體可包括如茶鹼（theophyiine),苯 妥英（phenytoin)或valproic酸，低分子荷爾蒙如甲狀組 (請先閱讀背面之注意事項再填寫本頁) 本紙張尺度边用中國國家標準（CNS)甲4規格（210x297公釐） -7 - 199858 Λ 6 Β6 經濟部中央標準局员工消費合作社印製 五、發明説明（6 ) 腺素，雌激素或estrdiol,癌症標誌例如CEA或AFP ,病毒如HIV, ATLA或HBV,高分子激素如促甲 狀腺激素（TSH)或胰島素，cytocain如IL-1, IL—2或IL一6,生長因素如EGF或PDGF,或 用於上述病毒的去氧核糖核酯或核糖核酸的抗體。這些抗 體可為單無性糸抗體或多無性糸抗體或可為 F (ab7) 2 , Fab', Fab其為抗體的碎片。抗 原可為病毒如HIV, ATLA, HBV,此病毒的去氧 核糖核酸，高分子激素胰島素，促甲狀腺激素等。 任何的前述不同標記化合物及放射性同位素仍可被使 用，雖然本發明只說明為使用酵素做為標記化合物。 、、 此㈣龙體或抗原可被附加到固相材料藉物理吸收或化 學鍵結。物理吸收之執行藉著界於固相材料及抗原或抗體 間的反應在一適當缓衝液中。至於缓衝溶液，可使用磷酸 鹽缓衝溶液，t r i s鹽酸缓衝溶液，碩酸鹽缓衝溶液等。 反應之完成可由混合及保持它們在攝氏4度到3 7度一段 時間，最好在室溫。化學附著之執行可藉使用在peptide 附著方法中之carbodimide方法。另一化學方法為一執行 在二價交叉鍵結試劑中之方法如戊二醛或cyanutric ch卜 oride (比較 Peptide 合成方法〃，Maruzen，1 9 7 5 或★酵素免疫試驗方法"，Kyoritsu Shuppan",、、蛋白 質核糖核酸酵素〃，特殊發表编號31,1987年）。 使用在酵素免疫試驗中之酵素標記抗體決定於一被測 量物髏且可為抗體辨識其表位等同於或不同於附加於固相 (請先閱讀背面之注意事項再填寫本頁) 本紙張尺度边用中圉國家標準（CNS)甲4規格（210x297公茇) -8 - 199858 Λ 6 Β6 經濟部中央標準局β工消f合作社印製 五、發明説明（7 ) 材料的抗體。此外，為了抗體偵測，抗體需對免疫液滴反 應。在抗體及酵素間的鍵結可藉已知共價鍵或非共價鍵獲 得（比較 ''蛋白質核糖核酸酵素〃，编號3 1 , 3 7頁到 4 5 頁，1 9 8 7 年）。 酵素使用包括過氣化物酶，鹼磷酸酯酶Ulkaliphos-Phatase),召一半乳糖苷酶，葡萄糖氣化酶及底質依據使 用之酵素及從ABS,魯米諾一過氣化氫用於過氣化物酶 ,p-nitrophosphate»methylunbelIifenyl phosphare， 3 _(2一 -pyr〇-tricyc1〇〔3.3-1.13，7 ]decan-4-methoxy-4-(3 " -phosphonyloxy-phenyl-1，用於齡碟酸醋酶之2-〇11〇-xetane discodium 鹽（AMPPD),用於 — 半乳糖苷 酶之 P_ni trophenyl-〇-galactose中選取。 顔色，螢光或亮度之測量藉由偵測裝置從一執行在攝 氏4度到4◦度的反應中。酵素免疫試驗測量可被達成藉 使用coloarimetry,螢光劑或化學發光。分光計，光計 數器等，或甚至照相膠片亦可被使用。此外，可能使用稱 為 ''加速方法〃，其中當試劑被加熱至4t：至4〇t：之溫 度範圍時，一測量被執行。 雖然本發明將參照酵素免疫試驗（EIA)詳細說明 ,要注意的是本發明亦可應用放射同位素免疫試驗（ R I A )或其他方法與某些測量部分的修正。用於放射同 位素免疫試驗，放射同位素如碘125,碘131,碩 14,氚等，被用做檫記以代替酵素。如同那些使用於酵 素免疫試驗的相同過程亦被用於放射同位素免疫試驗中除 (請先閱讀背面之注意事項再填寫本頁) 裝- 訂 線- 本紙張尺度边用中國國家標準（CNS)甲4規格（210x297公及) -9 - 199858 Λ 6 Β6 經濟部中央標準局貝工消費合作社印製 五、發明説明（8 ) 了放射性被測量外。在此種情形中，抗原或抗體的放射的 標記被輕易執行藉使用Bolton-Hunter試劑。例如，它可 被準備藉加Bolton-Hunter試劑到溶解在0. 1M的鈉氣 硪酸鹽水溶液之抗原或抗體溶液，且在1到2小時後，移 開不反應的Bolton-Hunter試劑藉由使用一 G — 2 5等的 去鹽柱。此外，1251的放射標記可被輕易完成藉使用 chloramine T方法或iododine方法。為了達成免疫反應， 一樣本披加到固相材料且反應在攝氏4度到4 0度，最好 在攝氏20度到38度，1到18小時，用生理食鹽水或 蒸餾水清洗且然後計算其放射性。一閃光計數器可用於此 測量。 必須注意根據本發明上述過程可以手動操作對於每個 儲存匣。亦卽，儲存匣本身的構造必須包含在本發明範圍 中。 ♦附圖簡述 圖1為根據本發明的一自動酵素免疫試驗裝置的外部 配置的透視圖； 圖1 A為根據本發明的一儲存匣平面圖； 圖1 B為圖1 A所示儲存匣的截面； 圖1 C到1 E各為根據本發明儲存匣的其他實施例的 截面； 圖1F顯示使用依據本發明之卡匣之測量的結果； 圖2為一透視圖概略顯示一本裝置的内部構造； (請先閲讀背面之注意事項再填寫本頁) 本紙張尺度边用中國國家標準（CNS)甲4規格（210x297公登） -10 - 199858 Λ 6 Β6 經濟部中央標準局貝工消費合作社印製 五、發明説明（9 ) 圖3為示於圖2的裝置的内部構造的平面圔； 圖4為沿圖3中線I V— I V的部分截面圖； 圖5A到5C顯示一用於本裝置的拾起裝置； 圖6A為一上昇機構的截面匾； 圖6B為沿圖6A中線V I -V I的截面圔； 圖7顯示一傾倒裝置的構造其用於傾倒所需溶液到儲 存匣的所需孔槽中經由藉此拾起之一薄片； 圖8為攪拌部分的截面圖； 圖9顯示無束缚分離器的另一修正與一無束缚分離器 —起； 圖1 0為圖9所示無束缚分離器的截面； 圖11為一截面顯示攪拌部分的另一實施例； 圖1 2顯示光測量部分的一實施例； ' 圖1 4顯示光測量部分的另一實施例； 圖1 5為圔1 4中所示光測量部分的平面圖； 圖1 6為顯示圖1 4中所示測量部分的結果圖； 圖1 7為一儲存匣配置器的平面圖； 圖18為儲存匣配置器的透視圖； 圖1 9為一流程圖顯示一步免疫試驗方法以使用根據 本發明的裝置執行； 圖2 0為一流程圖顯示兩步免疫試驗方法以使用根據 本發明的裝置執行； 圖21為一流程圖顯示延遲免疫試驗方法以使用根據 本發明的裝置執行；及 (請先閉讀背面之注意事項再填寫本頁) 本紙張尺度边用中國國家標準（CNS)甲4規格（210x297公釐） -11 ~ 199858 Λ 6 Β 6 經濟部中央標準局员工消t合作社印製 五、發明説明（10) 圖2 2為一流程圖顯示兩步免疫試驗方法使用稀釋劑 ，使用根據本發明的裝置執行。 ♦較佳實施例詳細說明 圖1為根據本發明的一自動酵素免疫測量裝置的透視 圖。 在圖1中，自動酵素免疫測量裝置1包括一罩框la 在其一較低部分中一儲存匣積存器30可移動的配置。儲 存匣積存器30積存多個儲存匣4在行及列矩陣中。一輸 入部分2包括一起動按鈕2 a及測量選擇按鈕2 b等，被 排列在罩框1 a的一側而一輸出部分3被配置在罩框1 a 的前板中。一處理部分10 (圖2)用來執行一条列混合 樣本與酵素標記物及底質，攪拌它們，在它們間引起反應 及測量反應的操作被配置在罩框1 a的上部。一蓮輸部分 用來蓮輸儲存匣及一控制部分用來控制糸列操作等，其未 示出，被容纳在罩框1 a中。 圖2概略顯示罩框1 a的内部構造。在圖2中，罩框 包括一較低階及一較高階。處理部分1◦包括，在較高階 ，一反應線11包括一對平行無端輸送機帶71其由一步 階馬達推動而儲存匣4沿其被順序移動。一稀釋部分25 ，一攪拌部分17,—磁分離器部分18,—清洗部分 19,一吸收傾倒/攪拌部分16,—測量部分20及一 排除部分2 1沿反應線1 1順序的配置。 一樣本積存器12被提供在較高階中其儲存多値樣本 (請先閲讀背面之注意事項再填寫本頁) 裝- 訂 線. 本紙張尺度边用中國g家標準（CNS)甲4規格（210X297公潑） -12 - 199858 Λ 6 Β 6 經濟部中央標準局β工消費合作社印製 五、發明説明（11) 44而一薄片積存器1 3用來儲存多値薄片1 3 a亦被提 供在較高階中緊鄰樣本積存器12。 吸收/分注傾倒部分16包括多値吸收/傾倒裝置 16a, 16b及16c沿反應線11適當排列用來吸引 一預設量樣本到一薄片13 a藉一適當幫浦機構，傾倒它 到傳送到反應線11之一儲存匣4的反應孔槽中，從一儲 存匣4的酵素標記物孔槽7 b或7 c吸收酵素檫記物質且 傾倒它到其反應孔槽藉此得到它們的混合液。 攪拌部分17攒拌在儲存匣的反應孔槽中的混合物使 得酵素免疫反應發生。攪拌部分17包括多個攪拌器 1 7a及1 7b沿反應線1 1適當排列。 磁分離器18包括多個分離器18a及18b排列在 沿反應線之適當位置。 〜 清洗部分19包括多個清洗裝置19a及19b配置 在沿反應線之適當位置。 上述部分在一控制部分5的控制下操作，此控制部份 5具有一包含用於不同酵素免疫測量的程式之程式記億體 2 2 ,如一步測量，兩步測量，延遲反應測量及用稀釋劑 兩步測量等。控制部分5尚包括一記億體23用來儲存需 用來從測量部分2 0的一輸出資料獲得免疫資訊之資訊及 一中央處理單元 2 4其一端連接到測量部分2 ◦的輸出且在另一端連接到 一輸出部分3和輸入部分2。中央處理單元24控制本身 控制部分22的操作。輸出部分3可包括一繪圖器及一顯 (請先閱讀背面之注意事項再塡寫本頁) 裝· 訂 線. 本紙張尺度逍用中國國家標準（CNS)甲4規格（210X297公釐) -13 - 199858 Λ 6 Β 6 經濟部中央標準局员工消费合作社印製 五、發明説明（12) 示器。 這些上述組成將在稍後個別參考圖2詳細說明，圖3 為示於圖2的裝置的詳細平面圖而圖4其為沿圖3中的線 I V - I V的部分截面圖。 如前所述，儲存匣本身的角色在本發明中非常重要。 因此，儲存匣將首先被詳細說明參考圖1 a到1 e而然後 將說明其準備及結果。 如圖1 a及1 b所示，儲存匡4包括一大致為矩形板 部分4 a其具有縱向端4 b凹口。這些凹口端用來使儲存 匣被穩定蓮輸。因此，任何突出可被形成在板部分4 a上 代替凹口。 至少兩個孔槽被形成在矩形板部分4 a中並列長度方 向如圖1 c所示，雖然示於圖1 a中的儲存匣4包括三個 孔槽4c, 4d及4e。每値孔槽的配置及深度可被任意 選擇視持定所需應用而定。然而，至少這些孔槽之一（ 4c)被做得深於其他孔槽，其原因稍後說明。孔槽4c 首先裝滿包括附著抗原或抗體之固相材料之溶液。固相可 為粒子或其一内壁其可被用做固相如前所述。為了保持此 溶液穩定，至少孔槽4c可藉一密封材料4f其可為鋁箔 ，高分子膠片，個別地或以粘合薄片形式而密封。密封4 f可藉一適當打破器當於使用時將其打破。 儲存厘4可由樹脂poly sthylene樹脂形成，如前所 述。代替凹口端1 〇b,亦可提供突出。儲存匣4的變化 各顯示於圖1 c, 1 d及1 e中。在圖1 C中，儲存匣4 (請先閱讀背面之注意事項再填寫本頁) 裝- 線· 本紙張尺度逍用中國國家標準（CNS)曱4規格（210x297公發） -14 - 經濟部中央標準局員工消費合作社印製 199858 Λ 6 _Β_6 五、發明説明（13) 具有兩個孔槽對應於圖Ip中的孔槽4c及4d,其可被 使用當不需任何稀釋操作時。在圖1 d中，儲存匣4具有 3値孔槽其中中孔槽有最小深度而其餘孔槽各相對於圔 1 a中的孔槽4c充滿相同附著固相材料之抗原或抗體。 此匣適於同時測量兩種血清。當這些較深孔槽被充滿不同 附著固相材料之抗原時，它可披用來同時測量兩種物體。 圖1 e顯示具有4個孔槽的儲存匣。此用來同時測量兩種 物體與稀釋操作。 回到圖1 a及1 b，孔槽4e被充滿血清或稀釋液且 可用來反應或稀釋操作而孔槽4 c用於反應在抗原的偵測 中或用於抗體偵測的稀釋操作。 現在，此儲存匣的準備將從一固相的準備開始説明。 I -儲存匣的進備 1 —筠酸化一锶酸鹽粒子 羧酸化鐵酸鹽粒子可被獲得藉由加入5 0毫升的3-a-minopropyltriethoxysilane到5克的鐵酸鹽粒子（聚乙稀 具有一平均核心粒子大小◦. 3徹米）其先前已被清洗5 次每6 0秒用蒸餾水清洗藉使用一超聲波清洗機（Bat t型 ，由 Nippon Seiki Seisakusho K.K.製造），另加入 3 ◦毫升的冰醋酸以反應在室溫下3小時，後隨清洗及與 s 1 utar i c酸脱水物反應。冰醋酸一滴滴加入在冰凍及攪拌 下，而每3次即以蒸餾水，甲醇及蒸餾水清洗，且另5次 (請先閲讀背面之注意事項再塡寫本頁) 本紙張尺度通用中國國家標準（CNS)甲4規格(210x297公货） -15 - 19&858 Λ 6 Β 6 經濟部中央標準局EX工消費合作社印製 五、發明説明（14) 以每3〇〇毫升的Ο. 1Μ鈉氫磺酸鹽溶液清洗。與gl_ utaric酸的反應可藉加入2. 85克的glutaric酸脱水 物到100毫升的5%重（Ο. 1M鈉氫碩酸鹽溶液）粒 子且反應10分鐘。在此反應完成後，混合物被清洗3次 用，以每300毫升的Ο.1M鈉氫碩酸鹽溶液，且另5 次用蒸餾水，這被用為羧酸化鐵酸鹽粒子。 2 —因相：附箸羧酴化鐵酴轉粒罕之抗T S Η抗體粒 在5毫升的20mM磷酸鹽緩衝液（酸鹼值4. 5) 中散佈5◦毫克I-1中準備的羧酸化鐵酸鹽粒子，隨後 加入5◦毫克的水溶碩化二亞胺。在在室溫下 反應20分後，表面浮物被移開，而5毫升抗TSH鼠 I gG抗體溶液（1毫克/毫升，Ο. 002M磷酸鹽缓 衝液，酸鹼值：4. 5),和此混合物被攪拌藉一端蓋端 攪拌器。在2小時後，這些粒子用2%BSA溶液清洗5 次（◦. 1M三氯化氫（Tris - HCP) ，ImM氯 化鎂，酸鹼值：7. 5)且散佈在相似BSA溶液中以得 到抗一TS Η —鼠I sG抗體感度羧酸化鐵酸鹽粒子。 2 —同相：结合牵孔槽壁表而之抗TSH —鼠I rG J.J- 扣.體 在圖1b中的儲存匣1〇的第一壁1〇b中， 200微升的抗一 TSH —鼠I gG抗體溶液（4徽克/ (請先閲讀背面之注意事項再填寫本頁) 裝· 訂 線· 本紙張尺度边用中國國家標準（CNS)甲4規格(210x297公釐） -16 - 經濟部中央標準局员工消費合作社印製 199858 Λ 6 ____Β 6_ 五、發明説明（15) 毫升，10mM磷酸鹽緩衝液，酸鹾值7. ◦)被傾倒且 維持在室溫18小時。孔槽用生理食鹽溶液清理3次而後 300微升的2%BSA溶液（Ο. 1Μ三氣化氫（ Tr i s— HC5) ，ImM氯化鎂，酸鹼值7. 6)被 加到其中，導致具有一孔槽之儲存匣與抗_TSH—鼠一 I g G抗體溶液結合。 3 —固相：結合聚乙烯粒子夕抗一TSH —鼠一 T g G抗體 1/8时的100個聚乙烯滴被浸入25毫升的抗一 TSH —鼠一 IgG抗體溶液（4微克/毫升，10mM 磷酸鹽缓衝液）且維持在室溫下一夜。這些滴用生理食鹽 溶液清洗3次而後2 5毫升的2 % B S A溶液（相同於上 述1)被加入其中，可得結合聚乙烯之抗一 TSH —鼠一 I g G抗體溶液。 I .用於T S Η測最的儲存匣的進備 1 一粒孑型儲存匣 25 ◦微升的抗—TSH-鼠一 I gG抗體結合準備 在I 一 2中之鐵酸鹽粒子（0. 04%粒子）被倒入儲存 匣4的孔槽4c在圖1b中而1◦0微升的鹼磷酸酯酶（ alkaliphosphatase)附加抗一T S Η —鼠一I g G — F a b抗髏溶液（包含〇. 1M三氯化氫（Tr i s — HCi? (請先閱讀背面之注意事項再塡寫本頁) 裝· 線. 本紙張尺度边用中國國家標準（CNS)甲4規格（210x297公茇) -17 - 199858 Λ 6 Β6 經濟部中央標準局员工消費合作社印製 五、發明説明（16) )，0 · ImM氯化鋅，ImM氣化鎂，酸鹼值7. 5, 2%BSA, 5 0 0毫微克/毫升鹾磷酸酯酶（alkaliph-osphatase)附加抗-τ SH -鼠—I g G-F a b 抗體） 被倒入第二孔槽4 d。這些儲存匣的孔槽由一具有一聚乙 烯基氣化物外覆附著表面且熱封合之鋁箔所覆蓋。所得之 儲存匣被用來做粒子型T S Η測量儲存匣。 2 —壁型餻存匣 1〇◦撤升的鹼磷酸酯酶附加抗TSH —鼠一 I gG 一Fab抗體溶液（包含◦.1M三氯化氫，0.ImM 氣化鋅，ImM氯化鎂，酸鹼值7. 5, 2%BSA, 500毫徹克/毫升鹾磷酸酯酶附加抗TSH鼠IgG_ Fab抗體）被加入孔槽4d中其包含抗一TSH—鼠一 I gG抗體準備在I 1_1中。儲存匣藉一具有一附著表 面外覆聚乙烯基氣化物之鋁箔而熱封。 3 —滴型餻fe匣 準備在1_1中的抗一TSH —鼠一 I gG抗體附加 聚乙烯滴之一被放入孔槽4 c中且2 5 0撤升的2%B S A溶液被加到其上。然後，1 ◦◦徹升的鹼磷酸酯酶束縛 抗一TSH —鼠一 IgG — Fab抗體溶液（包含◦. 1 Μ三氯化氫，◦. ImM氛化鈴，ImM氯化纟ϋ,酸齡值 7. 5， 2%BSA, 500毫撤克/毫升鹼磷酸酯酶束 缚反抗TSH鼠IgG Fab抗體）被倒入孔槽4e。 (請先閱讀背面之注意事項再填寫本頁) 本紙張尺度逍用中國國家標準（CNS)甲4規格（210x297公龙） -18 - 經濟部中央標準局貝工消贽合作社印製 199858 Λ 6 ____Β6_ 五、發明説明（17) 儲存匣藉一具有聚乙烯基氣化物外覆附著表面之鋁箔而熱 封。 Hi — ρ存匣的準備 附加鐵酸鹽粒子之1—HTLV—I抗原 鐵酸鹽粒子可從Nippon Paint Κ·Κ.得到，其被散佈 成800微升中10%含量2毫升，而HTLV—I抗原 ( 4 ◦◦微克/毫升）被加入其中，隨後以一端蓋端攪拌器 中在室溫下攪拌一夜。粒子用2%BSA溶液（◦. 1Μ 三氣化氫，ImM氯化纟ϋ,酸鹼值7. 5)清洗5次且散 佈在相同BSA溶液，以得结合鐵酸鹽粒子之HTLV— I抗原。 〜 I V —用於Η T L V — 了抗體偵測的儲存闸的進備 結合準備在Π — 1中之鐵鹽鹽溶液之3 5 ◦微升的Η TLV-I抗原（0. 008%/粒子/BSA溶液）被 倒入孔槽4c且300微升的抗一人體一IgG—鼠一 I gG抗體結合鹼磷酸酯酶被倒入孔槽4e。儲存匣藉一 鋁箔熱封。 V — T S Η的測最 在孔槽4 c , 4 d及4 e的密封藉密封打破器打破而 後一樣本包含50微升的TSH (◦,1◦徹U/毫升） (請先閲讀背面之注意事項再填寫本頁) 裝· 訂 線. 本紙張尺度边用中S國家標準（CNS)甲4規格（210x297公:¢) -19 - 199858 Λ 6 Β6 經濟部中央標準局員工消費合作社印製 五、發明説明（18) 及50微升的抗TSH Fab/抗體附加驗磷酸酯酶單 細胞結合（單細胞结合含量0. 5微克/毫升，〇. 1M 三氣化氫，2%BSA, ImM氯化鎂，0. ImM氣化 鋅，酸鹼值7. 5)包含在孔槽4c中被加入孔槽4d且 混合。 1 一滴型T S Η測暈孔榷的測景 在10分鐘後，包含在孔槽4c中之30撤升的混合 液加入包含滴之孔槽4d並攪拌。在1◦分鐘後，表面浮 物藉用生理食鹽溶液吸引及清洗4次而移開。3 0 ◦撤升 的底質溶液包含100徹克/毫升的AMPPD (0. 1 Μ三態氣化氫，luM氣化鎂，0. ImM氛化鋅，酸鹼 值9. 8)被加入且允許在室溫反應。在反應後10分鐘 ，反應藉一光度計（Aroka K.K.)測量。結果顯示於圖1 f 中。 2 —壁型T S Η測最孔槽的消丨最 在10分鐘後，包含在孔槽4c中之30微升的混合 液被加入附加抗體之孔槽4d並攪拌。在10分鐘後，表 面浮物以用生理食鹽溶液吸引和清洗4次而移開。300 微升的AMPPD溶液用於V—1中被加入孔槽4c中且 被允許在室溫下反應。然後，在5分鐘後，反應藉光度計 測量。結果顯示在圖1 f中。 (請先閱讀背面之注意事項再塡寫本頁) 線· 本紙張尺度边用中國Η家標準（CNS)甲4規格（210父297公；4·) -20 - 經濟部中央標準局貝工消费合作社印製 199858 A 6 __B6_ 五、發明説明（19) 3 —滴型T S Η測鼉孔槽的測鼉 在1◦分鐘後，之包含在孔槽10c中之30微升的 混合液被加到包i抗體結合粒子之孔槽，攪拌且置放如前 所述10分鐘。孔槽4c被面對一永久磁鐵其表面磁場為 3〇00高斯以吸引粒子。表面浮物被移開藉吸取及，在 倒入生理食鹽溶液到孔槽4c後而移開，鐵酸鹽粒子被吸 引由相同磁石而表面浮物被移開藉移注。此處理被重覆4 次。300微升的AMPPD用於V—1中被加入孔槽 4c且得以在室溫下反應5分鐘而然後以光度計測量。結 果顯示於圖If中。 VI —使用HTLV-l I孔槽之HTLV-I抗髏的測 在孔槽4 c上的密封藉密封打破器打破而2 0微升的 血清被加到其中。此外，1 80微升的稀釋溶液（ ◦ . 1M三氯化氫，ImM氣化鎂，◦. ImM氣化鋅， 酸鹼值7. 0包含10%NRS, 2%BSA)被加其上 。2◦微升的稀釋血清被混合與HTLV—1抗原附加粒 子在孔槽中且在攪拌後放置如前在攝氏37度下10分鐘 。孔槽4d面對一永久磁石其表面磁場為300◦高斯以 吸引粒子。表面浮物藉吸取而移開而400微升的4%生 理食鹽溶液被加到孔槽4c且攪拌。鐵酸鹽粒子由相同磁 石吸引且表面浮物藉吸取移開。此處理重覆兩次。 25 ◦微升的抗一人體_ I gG抗體與I gG結合鹼 太认邙K/i 闲Ψ ® ffi艾找m(CNS) 杩格（210x297公綮） -21 ~ (請先閲讀背面之注意事項再填寫本頁) 裝< 訂_ 線- 199858 Λ 6 ___Β6 _ 五、發明説明（2C)) 磷酸酯酶溶液（3 0 ◦毫微克/毫升蛋白質溶液）被加到 孔槽4c且置放如前所述10分鐘。孔槽4c面對一永久 磁石其表面磁場為3000高斯以吸引粒子。表面浮物藉 吸取移開，然後，4〇〇徹升的◦. 4%生理食鹽溶液被 加入及攪拌。鐵酸鹽粒子藉相同磁石吸引而表面浮物藉吸 取移開。此處理被重覆4次。300微升的AMPPD用 於 V_ 1中被加到孔槽4 c且得以在室溫下反應5分鐘而後 藉光度計測量亮度5秒。。結果示於表1中。 (請先閲讀背面之注意事項再塡寫本頁) 裝· 訂 線< 經濟部中央標準局兵工消#合作社印製 太M m +因因宅过進（4拟柊m Γι 乂 297公货） -22 - 199858 Λ 6 Β6 五、發明説明（21) 經濟部屮央標準局员工消費合作社印製 表 1 Η T L V - I抗體的測量 樣本 計數（X 1 0 = 丨） ( 計數/ έ秒） 1 〇. 〇 〇 5 2 0 . 〇 1 1 僅缓衝液 3 0 . 〇 0 9 4 〇. 0 〇 5 5 0 . 〇 〇 8 1 〇. 〇 4 2 陰性血清 2 0 . 0 5 9 3 〇. 0 5 4 〜 4 0 . 〇 6 3 1 〇. 5 9 9 陽性血清 2 〇. 5 3 5 3 〇. 5 4 2 V H — C A 1 9 _ 9的測最 1 — CA 1 9 — 9抗體結合粒子的進備 (請先閱讀背面之注意事項再填寫本頁) 裝. 訂 線. 199858 經濟部屮央標準局3工消費合作杜印製 A 6 B6 五、4明#1 ^ 的方式中，抗CA19—9MCA敏感化 鐵酸鹽粒子被準備藉反應2毫克的抗CA19_9單無性 条抗體（MCA)且充分清洗它（◦. 004%粒子/2 %BSA, 0. 1M三氛化氫，ImM氣化鎂， 0.ImM氯化鋅，酸鹼值7. 5)。 2—用於粒子型CA19—9測最的儲存匣的進備 250徹升的抗CA1 9 — 9 —鼠—I gG抗髏敏感 化鐵酸鹽粒子被加到圖1c儲存匣4的孔槽4c且350 微升的鹼磷酸酯酶敏感化抗CA 1 9 — 9—鼠一 I g G — Fab抗體溶液（◦. 5毫克/毫升）被加到孔槽4d。 儲存匣藉一 P E T叠片鋁箔而密封。 3 — C A 1 9 — 9的測景 使用在V I - 2中的鋁密封預先藉密封打破器打破而 2 0微升的血清被加到孔槽4 c而在攪拌後放置如前 1 ◦分鐘。然後，孔槽4 c面對一永久磁石其表面磁場為 3 0 0 ◦高斯以吸引粒子。表面浮物藉傾析移開，然後， 〇.2%生理食鹽溶液被加入且攢拌。鐵酸鹽粒子由相同 磁石吸引而表面浮物以相似方式被移開。此處理被重覆兩 次。然後，250徹升的標記抗體溶液在孔槽4d中加到 孔槽4c且攪拌。在室溫1◦分鐘後，鐵酸鹽粒子被吸引 且表面浮物被移開。此處理被重覆4次。然後， 3 0 0微升的相同底質溶液用於I V中被加入且攪拌。在 (請先閲讀背面之注意事項再填寫本頁) 裝< 訂- 線· 太认袼尺泞ii m Ψ ® s ^:捸iMCNS)中4捣格（21 Οχ297公修） -24 - 199858 A 6 B6 五、發明説明f3) _ 室溫5分鐘备，藉光度計測量亮度5秒鐘。結果示於表2 中。 表 2 C A 1 9 — 9測量 血清樣本 計數 (X 1 0 3 )C A 1 9 - -9的 (計數/ 5 秒） (徹U / 毫升） 1 0 .2 0 8 1 .9 2 1 .4 0 8 1 9 .3 3 4 .5 6 〇 5 9 .5 4 2 .1 4 4 3 1 .6 5 8 .5 7 5 10 8 .9 (請先閱讀背面之注意事項再塡寫本頁) 裝· 經濟部中央標準局Μ工消費合作社印製 V JI —用於粒孑型C： A 1 9 - 9測畺的儲存匣的準値_ 25 ◦徹升準備在VI— 1的抗CA 1 9 — 9 —鼠一 I gG抗體敏感化鐵酸鹽粒子被加到圖1 d中儲存匣4的 孔槽4c及4c且350毫升的鹼磷酸酯酶敏感化抗 CA19 — 9鼠IgG — Fab抗體溶液（0. 5微克/ 毫升）被加到孔槽4 e。這些孔槽藉一 P E T叠片鋁箔而 熱密封。 1 一 C A 1 9 — 9的測量 密封於V Μ中的鋁藉密封打破器預先打破且每 2 ◦微升的不同血清各被加到孔槽4c及4c 而在攪 線_ 199858 A 6 B6 拌五S 0分鐘。然後，孔槽披面對一永久磁石其 表面磁場為3000高斯以吸引粒子。表面浮物藉傾析移 開，然後，加人0. 2%生理食鹽溶液且攪拌。鐵酸鹽粒 子由相同磁石所吸引而表面浮物被以相同方式移開。此處 理被重覆2次。然後，250徹升的標記抗體溶液在孔槽 4d中被加到孔槽4c及4c /且攪拌。在室溫1 ◦分鐘 後，鐵酸鹽粒子被吸引而表面浮物被移開。加入4◦◦微 升的清洗液且攪拌而鐵酸鹽粒子被再次吸引由相同磁石且 表面浮物被移開。此處理被重覆4次。然後，加入用於I V中的3 0 0微升相同底質溶液且攪拌。在室溫5分鐘後 ，藉光度計測量亮度5秒鐘。結果示於表3中。 表 3: CA19 — 9試驗 - 樣本儲存匣孔槽標本编號 計數（X103) (計數/ 5秒） (請先閲讀背面之注意事項再填寫本頁) 裝* 訂 線_ 經濟部屮央標準局員工消t合作杜印製 青 •νί 血 12 3 8 2 6 1X 2 2 8 4 *· ο 〇 4 5 6 〇 〇 〇 6 3 2 4 1 5 8 6 9 -26 - 199858 A 6 B 6 經濟部屮央標準局Μ工消费合作社印製 f ‘鹿敏感化鐵酸鹽粒子的準備 鐵酸鹽粒子可從Nippon Paint K.K.獲得其被散入 800微升中5%含量而20 ◦毫升的HBs抗原（ 400微克/毫升）被加入其中，隨後藉搜拌在一端蓋端 攪拌器於室溫下一夜。粒子用2%BSA溶液（0. 1M 三氯化氫，lmM氣化鎂，酸鹼值7. 5)清洗5次且散 入相同BSA溶液中，導致HBs抗原敏感化鐵酸鹽粒子 〇 X —用於粒子塑HT LV— I及HB s抗體偵測的儲存匣 的進備 350微升準備在Μ中的HTLV—I抗原敏感化鐵 酸鹽溶液（0. 008%/粒子/BSA溶液）被倒入圖 1 e中儲存匣4的孔槽4c中且350徹升的HBs抗原 敏感化鐵酸鹽溶液（0. 008%/粒子/BSA溶液） 準備在IX中被加到孔槽4d。然後30 ◦徹升的抗一人 體一 I g G —鼠一 I g G —抗體敏感化鹼磷酸酯酶被倒入 孔槽4 d。儲存匣藉一鋁箔熱封。 X I 二Η T L V — I 乃 H R S 的測最 · 準備在V中的儲存匣的孔槽4c, 4c 4d及4 d **上的密封藉由密封打破器打破且2 ◦微升的血清被加 到孔槽4d~。此外，180微升的稀釋溶液（◦. 1M 三氯化氫，1 m Μ氯化鎂，0 . 1 m Μ氯化鋅，酸鹼值 太蚯铬尺泞困因文鸪淮（CNSWMtU柊（:>10乂297公货） -2Ί - (請先閲讀背面之注意事項再填寫本頁) 裝· 訂 線· 1θ9858 五、發明説明（26) ^ ^ 7.0包含10% NRS，2%BSA)被加入其中。 每20微升的此稀釋血清與在孔槽4c中的HTLV—I 抗原敏感化粒子及在孔槽4c -中的HBs抗原敏感化粒 子混合。在攪拌後，這些孔槽置放如前在攝氏37度10 分鐘。然後，這些孔槽面對一永久磁石其表面磁通為 3 0 0 0高斯以吸引粒子。表面浮物藉傾析移開，然後， 加入◦. 4%生理食鹽溶液且攪拌。鐵酸鹽粒子由相同磁 石吸引而表面浮物以相似方式移開。此處理被重覆兩次。 每250微升的抗人體IgG—鼠一IgG抗體敏感 化鹼磷酸酯酶溶液（3 0 0毫微克/毫升蛋白質溶液）被 加到孔槽4c及4c/且置於如前1◦分鐘。鐵酸鹽粒子 被再次吸引由相同磁石而表面浮物被移開。此處理被重覆 4次。然後，用以V—1中300微升的相同AMPPD 溶液被加入且攪拌。在室溫5分鐘後，由光度計測量亮度 5秒鐘。結果示於表4中。 (請先閱讀背面之注意事項再塡寫本頁) 裝· 訂 線. 經濟部中央標準局貝工消費合作社印製 太g m Ψ因Κ定过淮（CNS)屮公货） -28 - ^99858 A 6 B6 77 五、發明説明0/) 表4 HTLV—I及HBs抗體的測量 樣本 計數（X103)計數/5秒） 孔槽 15(HTLV-I) 孔槽 16(HBs) 經濟部中央標準局貝工消費合作社印製 1 0 . 0 0 6 0 . 0 〇 2 2 0 . 0 1 7 〇. 0 0 9 僅缓衝液 3 0 . 0 0 6 0 . 0 1 2 4 0 . 0 0 9 0 . 0 0 6 5 ◦. 0 1 5 0 . 0 0 7 1 0 . 0 5 2 0 . 1 2 5 陰性血清 2 0 . 〇 7 2 0 . ' 1 3 2 3 0 . 0 5 9 0 . 1 1 5 4 0 . 0 7 8 0 . 1 3 1 1 0 . 7 2 6 0 . 9 2 6 陽性血清 2 0 . 7 1 8 12. 8 2 1 3 1 . 5 2 6 8 . 6 4 3 如說明準備適當的儲存匣被用在本裝置中。現在，本 裝置將被詳細説明參考圖3到1 7。 (請先閱讀背面之注意事項再填寫本頁) 裝· 線· -29 - 199858 經濟部中央標準局員工消費合作社印製 A6 B6___ 五、發明説明 (28) Μ存匣蒱存器 積存多値儲存匣4在行及列矩陣中之儲存匣積存器 3 1可移動地水平插入圖3中之裝置的較低階部分。 餻存匣葎輸機樣 如圔3及圖4中所示，一儲存匣蓮輸機構被配置在儲 存匣積存器31之上。此機構沿一儲存匣積存器31的插 入方向延伸且包含一對軌道2 2 1其垂直於其延伸方向配 置和可沿軌道2 2 1移動之一起重臂2 2 0。一儲存匣拾 取裝置3 3被裝於臂2 2 0上並可沿其移動。 一用來沿軌道221之移動壁220及沿壁220移 動拾取裝置3 3之一機構可被實用於任何己知機構中如使 用在Χ — Υ繪圔器中。在本實施例中，此機構之應用可藉 由使用可逆馬逹（未示出），滑輪（未示出）及佈線以一 已知之方式排列。 這些可逆馬達可由一適當的控制機構控制以使拾取裝 置3 3披移到一預設位置（在圖3中以Α表示）因此安排 在X—Y矩陣在儲存匣積存器31之儲存匣4上可被一個 値移到該位置。 拾取奘詈 拾取裝置33詳細示於圖5A到5C中。拾取裝置 33包括一垂直可移動鈎裝置。圖5A為一鈎裝置的前視 太饫/?3闲屮8!困玄找进（(：胳）中4拐格（210乂297公价） -30 - (請先閱讀背面之注意事項再填寫本頁) 裝- 199858 Λ 6 Β 6 經濟部中央標準局员工消費合作社印製 五、發_明説明（29) 圖顯示在一fe上位置。它被向下移動以抓住一儲存匣4的 相反端如圖5B中所示。圖5C為一拾取裝置33的側面 圖。在圖5A到5C中，拾取裝置33披移到一位置其中 一選擇的儲存匣4被配置而保持鈎裝置在圖5 B所示狀態 且當拾取装置3 3到逹在儲存匣積存器3 1上之儲存匣4 時，其鈎裝置更加降低以抓住儲存匣而後移動到預設位置 A。在位置A ,拾取裝置3 3更降低以放置儲存匣4在預 設位置A中。 拾取裝置3 3包括一大致C型的框3 2 1其可滑動地 與臂320及一對垂直桿322接合，此垂直桿322提 供於平行在C型框321的相反端部分間。一滑動部分 323可滑動地裝在桿322上。如圖5C所示，一側溝 3 24形成在滑動部分3 2 3的後側面中且一馬達3 24 固定裝在框321上。臂325的一端固定連接到馬達 3 24的一軸而臂3 2 5的另一端形成一突出3 2 6其為 可滑動地裝配在側溝324中。因此，當馬逹324轉動 ，臂325的突出326沿側溝324滑動，使得滑動部 分3 2 3鉛直推動。 一板部分3 2 7緊密的固定到滑動部分3 2 3的前部 分其間有一適當間隙。間隙由管腳3 2 8給定。一對凸輪 槓捍3 2 9配置在滑動部分3 2 3及板部分3 2 7間使得 槓桿可在管腳3 2 8周圍搖動。 一對鈎部分3 3 〇各安裝在板部分3 2 7的前表面 上可轉地在管腳331周圍。鈎33〇a形成在鈎部分 (請先閱讀背面之注意事項再填寫本頁) 裝 訂- 線· 199858 A 6 B6 經濟部+央標準局β工消费合作社印製 五、發明説明（3Q) 3 3 0的較低端部分而其較上部分為可轉動地連接凸輪槓 桿3 2 9的低端部分經由一形成在板部分3 2 7中之洞 333,使得它們各在管腳332附近可轉動。 鈎元件3 3 ◦藉彈簧3 34互相向内偏離如圖5Α所 示使得凸輪槓捍的右側，被反時針方向偏離。為了維持鈎 元件330在圖5Α所示狀態，凸輪槓桿329的順時針 移動各由停止器3 3 5限制。 當滑動元件330以馬達324的轉動而降低時，鈎 元件330降低如圖5Α所示狀態。當滑動元件323降 低超過一個程度其中凸輪槓桿3 2 9的較低端接觸框 32 1的較低邊，凸輪槓桿329的較低端部分向内移動 藉框32 1的較低邊。因此，鈎元件330互相轉開以打 開鈎33〇a對抗由彈簧334的偏離力。因此，儲存匣 4可藉此抓住如圖5B所示。因此，當滑動元件323向 上移動，儲存匣藉由鈎330a與彈簧334的幫助而向 上升起。 以此方式保持儲存匣4之拾取裝置3 3藉起重機構移 動到圖3所示預設位置A而後拾取裝置3 3再次降低以使 儲存匣4可從勾解下藉凸輪槓桿3 2 9的較低端與框 32 1的較低邊的接觸。接下來，拾取裝置33回到儲存 匣積存器31的下値位置。 并隆機構 升降機構3 2用來移動藉由起重機構蓮輸在較低階中 太认汴 R 冷 Li 屮 κ sriieSiCNS)中4紹以ί:Π0χ:297公资） -32 _ (請先閱讀背面之注意事項再填寫本頁) 裝- 訂 經濟部屮央標準局貝工消費合作社印製 199858 A 6 _B6 五、發明説明（31) 之儲存匣41升到較高階而然後到一反應線上。因此，升 降機構3 2被配置在位置A。 圖6A及圖6 B乃是沿圖6中線V I -V I的截面圖 顯示升降機構32。在圖6A及6B中，機構32包括一 筆直框406其具有一垂直槽409在其前壁中，一可逆 馬逹405 (圖6B)配置在框406的外面和一對垂直 排列的鐽輪401固定配置在框406中。鍵輪401之 一連接到馬達4 0 5的一軸使得一鐽4 ◦ 2可反向推動於 鐽輪401上藉此可在一限制範圍内如圖6A所示。一滑 動塊4 ◦ 8被框罩在可垂直滑動的框4 0 6中且具有一側 槽4 1 1其對框406的前壁開口。一臂404可滑動接 收在側槽4 1 1中。一横臂404的後端部分可轉動的連 接到一位置41◦在鍵402上使得，當滑動塊408在 框406中最低位置時，臂404完全縮回且，在通過框 中最高位置後，臂被完全縮回如圖6A中所示。詳細說， 臂4 0 4的前部延伸在框4 0 6上經由垂直槽4 ◦ 7且被 配備一拾取裝置33/其相似於蓮輸機構的拾取裝置33 。可逆馬達405可逆地推動鏈輪以使鏈402在鐽 402及横臂404後端的連接點41◦的位置B及C間 所限的範圍内往復移動因此臂4 04的前端沿一圖6 A中 虛線500所示軌跡移動。亦即，在圖6A中，完全縮回 臂404被移動藉鍵輪4〇1在箭號方向的移動到上鏈輪 的位置。然後，在沿上鐽輪401的一較上四分之一圓通 過後，横臂404向下移動而漸漸突出且，最後，它被完 (請先閱讀背面之注意事項再填寫本頁) 裝- 訂_ 線- 太仏择冷a m Φ a κ文找淮（CNS )甲4扣格C10 X 297公足） -33 - 經濟部中央標準局貝工消費合作社印製 1998Κ« _Be_ 鐽輪的後四分之一圓之移動。 横臂4 0 4的前端的移動的上端部分的半圓軌跡及拾 取裝置3 3 >因此是重要的鑑於儲存匣的穩定平移到反應 線1 1上。 拾取裝置33/之抓取及放開操作對應於儲存匣4相 同於對應圖5A及5B所述。亦即，在臂404的較低位 置，滑動元件降低以抓住儲存匣而後向上移動。然後，裝 置33>與臂404—起沿軌跡500的虛線移動，而在 軌跡5〇〇的末端，滑動元件被再次降低以放開儲存匣到 反應線11上。 I.較上階取樣器部分的结構 如圖3所示，一取樣卡匣12及一樣本匣13被配置 在一第二，上階中。取樣卡匣12包括多値取樣片44排 列在一水平面中而樣本匣1 3包括多個樣本容器1 3 a， 其每個包含一樣本液内含待測量物質，排列在一平面中。 反鹿猱1 1 反應線11大致延伸在一垂直儲存匣積存器31的插 入方向的方向中在較低階。反應線1 1包括一對平行環帶 7 1如圖2及3中所示。環帶7 1各支持每個儲存匣4的 相反端部分，使得儲存匣可被穩定沿其移動。環帶71被 配置在反應線1 1的相反端部分中之鐽輪72而推動，鐽 輪72乃由步階馬達交替的推動，使得放置在反應線上的 (請先閲讀背面之注意事項再填寫本頁) -34 - 199858 經濟部中央樑準局貝工消費合作杜印製 五、發明説明（33) 儲存匣可被步進一時段，例如30秒。 藉升降機構32升起並放置在反應線11的起動部分 上的儲存匣4被步進到在反應線11上的下一位置在 3 0秒後而這被重覆直到一測量完成。有許多裝置沿反應 線1 1配置，以用以産生一所需反應。此種裝置將在稍後 詳細說明。 密射打破器 如前述，儲存匣4置放在反應線11的起動點上具有 由密封膠片1 1 f密封的孔槽。為了移開此密封，一密封 打破器40被提供在反應線11之上在相郯起動點的位置 。在所示的實施例中，密封打破器採取一方塊形式其具有 一較低表面形成與多個（在此情形，3個）向下突起使得 ，藉降低方塊，在儲存匣的各別孔槽中之密封膠片11f 的部分藉突起而打破以使這些孔槽可用。因為此種方塊的 設計是任意的而那些純熟於本技術的人士能輕易設計它， 這褢將不説明其細節。 樣本耜動機構 如圖2到4所示，一樣本蓮輸機構被提供在較上階之 上，其具有大致上相同於儲存匣運輸機構的構造除了一取 樣幫浦單元8 2被裝在一臂8 1上代替拾取装置3 3。在 軌道80中，臂81可沿軌道滑動8◦且裝在臂81上之 取樣單元82可沿其移動。幫浦單元82的移動在一平面 (請先閱讀背面之注意事項再填寫本頁) 訂' 線_ 太饭择Rm屮@3函它锶中4码柊门1〇乂297公贷） -35 - A 6 B 6 199858 中五夫ϋ黑€ i置3 3相同。 (請先閱讀背面之注意事項再填寫本頁) 敗様幫浦菫元 圖7所示取樣單元8 2包括管嘴8 2 1及一幫浦部分 8 2 2皆配置在一箱8 3内且藉一適當管8 24而互相連 接。管嘴部分821包括一管嘴823其被穩固到一例如 可藉一螺管而垂直可動之板8 2 5。當管嘴8 2 3被降低 ,其一頂端接合一薄片44在取樣卡匣12中。然後，它 被上升及移動以帶薄片44到一適當位置其中幫浦部分 8 2 2被起動以吸引一包含在其内之液體而後移到另一位 置以將其倒出。後來，移到一位置d (圖3)以配置使用 的薄片到薄片配置器7 0 ◦中。 播拌部分及無東缚分離器 經濟部中央標準局员工消費合作社印m 圖8及9顯示一攪拌部分的實施例。在圖1 0中，其 為一攪拌部分的截面圖，一棒501具有一端離心的連接 到馬達5 04的一軸而另一端裝置一 U型元件5 0 2。棒 50 1的中間部分藉一支撑器503彈性支撑。U型元件 5 ◦ 2被調整以適合地接收由環帶7 1所蓮送之儲存匣4 的第一孔槽。當馬達504轉動時，棒50 1藉此被振動 地推動以振動U型元件5 0 2使得其中接收的第一孔槽被 振動以攪拌其内含物。在圖9中其為一平面圖顯示圖8所 示的攪拌部分的修正，一橫樑5 04被穩固到棒50 1的 中間部分而棒5 0 1具有一端離心連接到一馬達軸而另一 太R iA ffl Φ S a -iat迆（CN'S) ¥4扭格公贷） -36 - 199858 A 6 B6 經濟部中央標準局貝工消費合作社印製 ^503 /彈性支撑。從横樑504的相反 末端部分一對棒50 1 a及50 1 b延伸出。棒50 1 a 及5〇 1 b的末端各安裝U型元件5〇2a及502b。 在U型元件502間，一磁性無束缚分離器90被配置。 無束缚分離器9 0包括一永久磁石9 2由一磁性元件 9 1支撑配置在儲存匣4的第一孔槽的一通道的一側如圔 10所示。藉通過磁石92,其中的磁粒子被吸引到儲存 匣孔槽的壁且，藉用適當清洗液清洗該孔槽，自由抗原或 抗體可被移開。 圖1 1顯示攪拌部分的另一實施例。在此實施例中， 一大體圓柱元件618其材料比重相當大具有一盲洞 6 2 0及一凸輪斜坡6 2 2藉切割形成在圓柱的一壁中。 一塞元件6 14被插入盲洞620中。塞元件6 14具有 一盲洞於此一直立馬逹610的軸被穩固定插入。塞61 4具有一突起6 1 6其跟隨凸輪斜坡。在圓柱6 1 8的盲 洞6 2 0的底部，一離心洞6 2 4被形成以使管腳6 2 6 被固定插入。一孔槽接收器元件628可被轉動支撑著藉 著一管腳6 2 6的暴露部分經由一支架6 2 7。孔槽接收 器元件628其上具有一凹洞於此孔槽被接收。由於重量 ，圓柱元件618傾向下落由於重力關傜。因此，在不操 作中，它是完全降低使得塞614的突起616接觸凸輪 斜坡622上的最上位置。當馬達610反時針方向轉動 ，塞614被反時針方向轉動，使得其管腳616推圓柱 6 1 8沿凸輪斜坡622向上。當圓柱6 1 8達到最上位 (請先閲讀背面之注意事項再填寫本頁) 訂. 線< 太蜣馁尺没π闲屮因κ它it驻（CNW4抝格ΓΠ0Χ297公访） -37 - 199858 A 6 B6 經濟部屮央標準局貝工消費合作社印製 五、發明説明（36 ) 置在那褢孔槽接收器628接收孔槽，圓柱618反時針 方向轉動而保持相對孔槽位置關傜如前。因為接收器 628稍稍相對於圓柱618離心，接收器628振動地 轉動，使得孔槽的内含物被搜拌。 圖1 2為顯示攪拌部分的另一實施例。在圖1 2中， 一直立馬逹6 5 0被配置在璟帶7 1間以一種方式使得它 可被鉛直移動藉由，例如，一安裝在一横軸654上之凸 輪元件6 5 2並接觸馬達6 5 0的一底部。在馬達的一軸 上，一孔槽接收器6 5 6離心地可轉動地安裝經由一支架 6 5 8。在馬達的較上位置，孔槽接收器可接收之由帶子 7 1搞帶之儲存匣孔槽4c的底部部分，在馬逹的更往上 的移動，孔槽吸收器推儲存匣往上。 當儲存匣被大致推向上時，它毗連形成在一支持元件 6 6 2的一較低表面之儲存匣導引6 6 0在相對於儲存匣 的凹槽的位置。一支持元件的鉛直可移範圍被限制藉其側 管腳6 6 4與形成在大致反U型框6 6 8中的鉛直槽 666的接合。在支持物及框的頂部分間，一支點元件 670被提供，其具有一指向低端其被接收形成在支持元 件的上表面上之一洞或凹洞672中。支點元件藉一彈簧 6 7 4向下偏離以藉此偏離支持元件向下。 當馬達向上移動到最上位置藉曲輪元件，它被能量化 以離心轉動孔槽接收器以藉此攪拌孔槽的内含物。在此情 形中，因為支持元件穩定支持儲存匣的上部，孔槽接收器 的離心振動蓮動可被有效地傳到孔槽，導致充分攪拌的獲 太畝筷Η泠消m Ψ因κ它找漼iCNSVH卸枋QlOy 297公妤） -38 - (請先閱讀背面之注意事項再塡寫本頁) 裝- 訂_ 線- 199858 Λ 6 Β6 經濟部中央標準局员工消費合作社印製 、發明説明（3 ) 當多値此種搜拌部分沿反應線配置，於此之馬逹65 ◦的鉛直蓮動可藉相同曲輪元件分別的控制對其（6 5 2 )以不同角度安裝在相同軸。 測鼉部分 圖1 3顯示測量部分2 0的一實施例。這用來測量酵 素的亮度束缚與磁粒子攜帶抗原或抗體一持定波長。它包 括一反射鏡720,—部分反射鏡721及一光電倍加器 722。在此實施例中，一時間的亮度由光電倍加器72 2經由反射鏡720及部分反射鏡721而測量，而下一 時間的亮度直接經由部分反射鏡7 2 1而測量。一旋轉器 可附加其上以移開由於不正常反射光所致的錯誤，如果有 需要的話。 圔1 4顯示測量部分的另一例子。在圖1 4中，儲存 匣4的第一孔槽4 c於此所需反應將被測量乃被接收在一 光反射圓柱730的上開口中以一向下發散洞的形式，此 發散洞形成在一方塊元件732中，而方塊元件732乃 提供在形成在第一卡昼734中之洞上，而其一上周大致 相同於孔槽4c。一圓柱7300的錐形牆736的一角 度α可在10度到60度的範圍内。然後，已發現一滿意 之結果獲得為當角度為3 0度時。 一第二卡疊7 3 8被提供在卡叠7 34之下而互相平 行。第二卡叠8 3 7具有一洞相對於，在位置及大小，第 太蚨语Η泠iij闲Ψ因K 拟格（21〇乂297公访) - 39 - (請先閱讀背面之注意事項再填寫本頁) 装- 訂 線. 199858 A6 __B6_ ., 38 k釦洞。一光電倍增器740被配置相對於圓 柱7 3 0在第二卡叠7 3 8之下藉一適當機構。 一過濾器7 5 ◦被配置在第一卡昼及第二卡β間。過 濾器7 5 0包括一碟片7 5 2其藉一支持在這些卡疊間之 管腳754而可轉動的支持著。碟片752具有多個洞7 56沿其一周圍部分形成，在每値洞中配置有一過濾器元 件 7 5 8 〇 碟片的周緣被齒連以嚙合一齒輪7 6 0其安裝在馬逹 7 6 2的一軸上以使碟片7 5 2藉馬達7 6 2而轉動以放 置一所需過濾元件7 5 6恰在圓柱7 3 0及光電倍增器 74◦間的位置。圖15顯示一碟片752,馬逹762 及齒輪7 6 ◦的相關位置。 3個過濾元件750提供在所示實施例中，其各具有 1%, 10%及100%之透光的。過濾元件的數目及它 們的透光性可視需要而選擇。 經濟部屮央標準局員工消費合作社印製 (請先閱讀背面之注意事項再填寫本頁) 一位置感測器7 7 0提供在碟片7 5 2上以偵測碟片 的一轉動角。感測器7 7 ◦可為一磁感測器。根據感測器 770的一輸出，馬達764被控制以定位一所需過濾元 件在適當位置。 圓柱730的錐形牆736如前所述是重要的。圖 1 6顯示用來解釋錐形圓柱的效果的實驗的結果。在此實 驗中，0. 1Μ三缓衝溶液（酸鹼值9. 8) ，2 ◦微升 的龄磷酸酯酶（1微克/毫升）及3 ◦◦微升的ΑΜΡΡ D的混合的亮度由具有和不具有3◦度之錐形角的圓柱 κ /i iS m Ψ ® ffi titafCNS'l Ψ4»^ί210 xZ97^ 一 4·0 _ 199858％蟹潮豹 A 6 B 6 經濟部屮央樑準局员工消t合作社印製 鏟存匣配置器 圖1 7為儲存匣配置器的一平面圖而圖1 8為圖2中 所示儲存匣配置器21的透視圖。在圖17和18中，儲 存匣配置器21被配置在反應線11的一末端部分於此儲 存匣被完全到達一個接一個測量。配置器包括一臂升高裝 置926其裝在基座924上。升降裝置934包括一對 垂直軌942,—由軌道支持垂直且可滑動地之凸輪方塊 934,—直流馬達922具有一支撑一碟M938之軸 被提供在其周圍且含有一滾輪9 4 0其與一水平形成在凸 輪方塊934中之凸輪槽接合，一方塊920穩固到凸輪 方塊934上且框罩一步進馬逹，一臂928其一端固定 連接到步進馬達的一軸及一拾取裝置9 3 2被装在臂 9 2 8的另一端上。 拾取裝置9 2具有大致相同如儲存匣起重機構的拾取 裝置33之構造，而某些部分被移開。 在操作中，凸輪方塊934藉馬逹922的轉動經碟 片938沿軌道942而升起，於此滾輪94◦與凸輪槽 936接合。然後，方塊92◦的步進馬達被起動當一儲 存匣到逹反應線的末端以帶動臂9 2 8的另一端且因此拾 取裝置932在到達之儲存匣之上。其後，凸輪方塊 9 34被降低到儲存匣上使得拾取裝置9 3 2能抓住儲存 厘以相同方式如所述對應於儲存匣蓮輸機構的拾取裝置 (請先閲讀背面之注意事項再塡寫本頁) 裝 訂 線· -41 - 19^^58 A 6 B6 ,40、 經濟部屮央標準局貝工消費合作社印製 ?繁墨輪方塊被再次升起且背 928在反向方向 轉動在配置器容器916之上。在此位置，拾取裝置 932被起動以鬆開儲存匣而允許它掉進容器中。此操作 順序被重覆當每個儲存匣到達。 圖19到22各顯示一步方法，兩步方法，延遲方法 及具稀釋的兩步方法的流程圖，相關的由本裝置執行。在 這些流程圖中，對所有這些方法步驟S1及S2皆相同。 在步驟S1中，一操作者起動輸入部分2的起動鈕2 a使 得在儲存匣積存器中的儲存匣的蓮輸被起始一個接一個到 起動位置於反應線上經儲存匣起重機構及儲存匣升降機構 且相繼地經密封打破器打破儲存匣的密封在反應線上（步 驟S 2)。然後操作者操作其選擇鈕2b以選擇一程式相 對於一欲得的一反應。中央處理單元24從程式記億器謓 出選擇程式且開始控制裝置的不同部分的操作以使選取的 程式可被執行。 在圖19中其顯示上述的一步方法，取樣起重機構及 吸取/分注傾斜部分被起動以拾取一薄片其中一樣本被取 入藉吸取及分注傾倒入儲存匣的第一孔槽，其包含磁粒子 攜帶抗原或抗體，而，在薄片被配置後，拾取另一薄片其 中包含在儲存匣第二孔槽中之酵素標記物被取入及倒入第 一孔槽（步驟S3)。然後，第一攪拌部分17a被起動 以攪拌儲存匣第一孔槽中的混合物移動到下一位置在反應 線70上（步驟S4)。然後，當儲存匣到達一第一磁無 束缚分離器18a，一無束缚分離器被執行，隨後藉由第 (請先閱讀背面之注意事項再填寫本頁) 太f! Φ ® ffi KiSmiCNS) Ψ4相.柊ί:·Μ0χ297公货） -42 - 19985& A 6 B 6 經濟部中央標準局员工消#合作社印製 五、發明説明（） 一清洗部分19a清洗（步驟SI 1)。然後，底質藉底 質傾倒部分1 6 c加到第一孔槽且在第二攪拌部分1 7 b 中攪拌（步驟S 1 2 )。然後，一光測量披執行藉測量部 分20 (步驟S 13)且其一輸出被供應到中央處理單元 24 (步驟S 14)。同時，儲存匣被配置藉配置部分（ 步驟S 1 5 )。 圖2◦顯示上述兩步方法。在步驟S2後，一樣本被 倒入儲存匣的第一孔槽，其包含磁粒子攜帶抗原或抗體（ 步驟S5)。然後，第一攪拌部分17a被起動以攪拌在 儲存匣的第一孔槽中的混合物移動到下一位置在反應線 7 ◦上（步驟S6)。然後，當儲存匣到達第一磁無束缚 分離器18 a, —無束缚分離器被執行，隨後藉由第一清 洗部分19a清洗（步驟S7)。然後，包含在儲存匣第 二孔槽中的酵素標記物被倒入第一孔槽且攪拌（步驟S 8 )。其後，一磁無束縛分離及清洗被執行在步驟S 9中。 然後，在在步驟S 1 ◦中再次攪拌後，底質由底質傾倒部 分16c加入第一孔槽且在第二攪拌部分17b中攛拌（ 步驟S 1 2 )。然後，一光測量被執行由測量部分2 0 ( 步驟S 13)且其一輸出被供應到中央處理單元24 (步 驟S14)。同時，儲存匣被配置藉配·置器部分（步驟S 15)。 圖21顯示上述使用稀釋的延遅方法其中步驟S1到 S4相同於圖1 8中。在步驟S4後，包含在儲存匣的第 一孔槽中之磁粒子攜帶抗原或抗體被與一樣本混合且酵素 (請先閲讀背面之注意事項再塡寫本頁) 裝· 訂 線_ A 6 B6 199858 合物被攪拌藉第一搜拌部分（步驟S51 )。然後，步驟S9到S 15被執行對應如圖20所示。 圖2 1顯示使用稀釋之兩步方法。在圖2 2中，在步 驟S2後，稀釋液從稀釋部分25被倒入儲存匣的第一孔 槽（步驟S6 1)且一樣本被倒入同一孔槽（步驟S5) 。結果的稀釋樣本被倒入一包含磁粒子攜帶抗原或抗體之 第二孔槽（步驟S62)。然後，經由第一攪拌部分17 a攪拌後（步驟S 6 3)，一無束缚分離及清洗被執行在 步驟S7中。其後，相同圖20的兩步方法中的步驟8到 1 5被執行。 如前所述，根據本發明，用來執行一免疫試驗測量的 操作順序可完全自動藉由使用每個具有至少兩個孔槽的儲 存匣，至少其中之一包含固相材料，和用來一個個步進移 動這些儲存匣的反應線當執行相關於儲存匣所需之操作時 藉由至少一無束縛分離器，至少一攪拌器，至少一傾倒部 分，至少一清洗部分，一光測量部分，等等，沿反應線以 適當順序之順序配置。上述儲存匣可被各別修正以適合所 需應用。本裝置的構成部分亦可被適當修正。此種修正亦 包含在本發明的範圍中。 (請先閲讀背面之注意事項再塡寫本頁) 裝- 線. 經濟部中央標準局员工消費合作社印製 *** 44 -Printed by Beigongxiao # Cooperative, Central Bureau of Standards, Ministry of Economic Affairs 190858 Λ 6 __Β6_ V. Description of the invention (1) ♦ Background of the invention The present invention is about an automatic immune device and its use method. Immunoassays are generally performed by using different labeled compounds such as enzymes, fluorescent substances such as fluorescein or rhodamine, luminescent substances such as acridinium ester (ac_ridinium ester), luminol (isoluminol) or isoluminol ( isolum -i no 1) and radioisotopes such as iodine 125, iodine 131, Shuo 14 or tritium. Radioimmunoassays using radioisotopes such as labeled compounds (RIA) and enzyme immunoassays using enzymes as labeled compounds (E IA) are known. Among them, the enzyme immunoassay (E IA) has been widely used, especially in the field of clinical testing in view of its discrimination and sensitivity. In the Enzyme Immunoassay (E IA), it is usually combined with the selection of an antigen or antibody against a pending object, that is, the antibody or antigen is measured to the solid phase material and the solid phase material with the selected antigen or antibody is allowed to be contacted. This causes an antigen-antibody reaction to take place in the sample solution. Enzyme-labeled reactions or bound antigens or anti-skeletons are separated from non-reactions, that is, free enzymes label antigens or antibodies. After separation, it is usually called unbound (B / F) separation, and the action of labeling the reaction substance enzyme is measured, so the measurement object in the sample is quantitatively measured. Therefore, in order to perform an enzyme immunoassay (EIA), a number of very complex procedures, such as a small increase in reagents, dilution, stirring, unbound separation, solid phase displacement, etc. are required. The solid phase materials used in the enzyme immunoassay (E IA), polyethylene particles, magnetic particles and the inner wall surface of a reaction chamber are known. Some improvements have been proposed in enzyme immunoassays. One of them is one (please read the precautions on the back before filling in this page). The binding line. This paper uses the China @ 家 标准 （CNS) 曱 4 specifications (210x297 public splash) -3-199658 Λ 6 Β6 Ministry of Economic Affairs Printed by the Central Standards Bureau employee Xiao # Cooperative V. Description of the invention (2) The improvement of the reagent container used in the enzyme immunity test. Japanese 〖(^ -ai (P) 62 — 27345 describes a technique for performing enzyme immunoassays with high silkworm sensitivity, in which magnetic particles are used as solid materials without binding separation and a special container is used to contain this one Magnetic particles and a magnetic separation device with a permanent magnet arranged relative to the container are executed. In addition, Japanese Kok-ai (P) 1-20 1 1 56 illustrates this technique in which a full plate is used to contain magnetic particles and a magnetic Separator. Japan 1 (〇1 ^ 丨 (?) 63-2 8 1 0 5 3 shows that a container has multiple wells such as reaction wells and sample wells, etc., arranged in a matrix. On the other hand, it is used for measurement One of a large number of samples, a semi-automatic measuring device has been developed, for example, shown in E. Ishikawa, '' Enzyme Immunoassay 〃, Igaku Shoin, 1 8 ◦ page to 2 ◦ 7 page. However, it is known that in any known method It takes 1 hour to 18 hours to perform manual measurement in the device and even if the magnetic particles are used as solid materials. That is, the traditional semi-automatic device is used, this time cannot be sufficiently reduced due to some complicated procedures still required. An eye To provide an automatic device for enzyme immunoassay (EIA) or radioisotope immunoassay (RIA), which can measure some of the same and / or different test items that require different measurement processes, for each item in a very short time. Another purpose is to provide an immunization method by using the device of the present invention. (Please read the precautions on the back before filling this page) 装 · * 1T < Line · This paper scale uses the Chinese Gujia Standard (CNS) Grade 4 specifications (210X297 public splash) -4-Printed by the Beigong Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 199858 Afi A o __B6_ V. Description of the invention (3) Another object of the present invention is to provide a reaction storage box for use in an automatic device. According to the present invention, the above objectives and other objectives can be achieved by providing an automatic immune device for measuring antigens or antibodies in a measurement object such as serum or human. The device includes a sample storage part for storing multiple samples, a reagent storage part for storing cleaning and / or diluent, and a reaction storage cartridge accumulator part for storing multiple reaction storage cartridges. Plastic · Materials such as polystyrene resin, polypropylene resin, polyvinyl chloride resin or glass and formed into at least two parallel slots, the first slot is used to store the solid phase carrying antigen or antibody The second hole of the material is used to store the labeling substance, which is an antigen or antibody label and a labeling compound, a reaction line part is used to sequentially move the reaction storage box, and a reaction storage box transmission part is used to transfer the storage box from the reaction storage box Accumulator to a reaction line starting position one by one according to a measurement item, a suction / dispensing pouring part is placed at a downstream position along the reaction line for pouring each sample in the sample storage part and moving to this storage in the storage box The material in the second hole of the tank goes to the first hole of the storage box to obtain their mixing. At least one mixing part is used to shake the storage box to stir and mix In a first aperture slot, the at least one magnetic separator for magnetically unconstrained from the first hole of the tank is not intended reaction mixture was stirred for partial separation of the reaction section. A cleaning part is used to remove the unreacted part from the first hole, a pouring / stirring part is used to spread the bottom layer solution to the first hole and stir it, and a measuring part is used to optically measure the first hole The luminescence information generated by the reaction between the bottom layer and the reaction part in the middle boundary, an output part is used to output a measurement obtained in the measurement part, and a configuration part is mentioned (please read the precautions on the back before filling this page) Thread · This paper uses the Chinese National Standard (CHS) A4 specification (2 丨 0x297 male dragon) -5-199858 Λ 6 Β6 Printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economy V. Description of invention (4) for response Around the end portion of the wire is used to configure the measurement completed by the storage box and a control portion is used to control the operation of the above portion. Some of these components may not be used in the holding measurement or the order of their use may change because the immunoassay may be performed in a different process. In addition, the number of holes in the storage box and the volume or depth of these holes can be changed according to requirements. There are basically two measuring methods known. One of them is called "one-step" method for measuring antigens or antibodies and the other is called "two-step" method. This one-step method includes two changes each of which can be applied to antigen or antibody measurement. In a variation, the ligand and labeled antibody are added to the solid phase material simultaneously and the bottom layer is added to it after an unbound separation is performed. In another variation called the delay method, a mixture of ligand and labeled antibody is added to the solid phase material and then an unbound separation is performed after the addition of the bottom layer. Therefore, in the a-step " method, the number of holes of the storage box may be two and a single unbounded level may be sufficient. 1 The two-step method is divided into an antigen measurement method and an antibody measurement method. ./ In the antigen measurement method, the solid phase material and ligand (lUand) are mixed in the first well. After washing, the enzyme-labeled antibodies are mixed together, and then after the unfettered separation is performed, the target is added. In the antibody measurement, the antibody is diluted and then mixed with the solid phase material. After cleaning, after the marker body is added, an unbound separation is performed and then the bottom layer is added. In the "two-step" method, a pair of unbound devices is required and the number of holes in the mother storage box can be 3. Although the storage case may be formed of any of the above materials, it may be most suitable in view of cost and light-transmitting polystyrene resin. In addition, the storage box is formed on the side of the photo paper and uses the Chinese National Standard (CNS) A4 specifications (210x297 gong) -6 ~ (please read the precautions on the back side before filling out this page). Packing-Line · 199858 Λ 6 Β 6 Printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs 5. Description of the invention (5) The reverse end has a recess or protrusion to stabilize its state during processing and the hole must be sealed with a suitable sealing film so that it can be carried, for example The reagent of the solid phase material of antigen or antibody can be stably stored in these wells until it is used. As for the sealing film, aluminum foil, many polymer films can be used singly or stacked. In use, the sealing film can be broken by a suitable breaker. In addition, it is possible to measure two different items of the same sample at the same time by storing different solid materials in different wells of the storage cartridge with different antibodies. In addition, the two samples can be processed simultaneously by storing the solid phase material in different wells of the storage cartridge carrying the same antibody. In this case, the number of holes in each storage box must be four or more. One of these wells can be used as a dilution well where the sample is diluted. The wells of the well-storage cartridges that receive the solid-phase material carrying the antibody must have a large volume and be deeper than the other wells to allow the addition of the reaction solution thereon and aid in the external detection of a reaction. The solid phase material used in the present invention may be an inner wall of the pores of the storage box itself, particles or particles. Such particles may be polyethylene. As for the particles, particles of magnetic materials or particles containing magnetic materials are suitable. In particular, ferromagnetic particles may be most suitable for this purpose. When the solid-phase material is a magnetic particle, unbound separation can be put into a hole in a storage box containing such particles, by applying an external magnetic field to it. That is, the above-mentioned device can be applied to any of these methods by changing the processing program stored in one hundred million volumes in the control section. Antibodies used in the present invention may include, for example, theophyiine, phenytoin or valproic acid, low molecular hormones such as thyroid group (please read the precautions on the back before filling this page). Standard (CNS) A4 specifications (210x297 mm) -7-199858 Λ 6 Β6 Printed by the Employee Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs V. Description of invention (6) Adenosine, estrogen or estrdiol, cancer mark such as CEA or AFP , Viruses such as HIV, ATLA or HBV, high molecular hormones such as thyroid stimulating hormone (TSH) or insulin, cytocain such as IL-1, IL-2 or IL-6, growth factors such as EGF or PDGF, or for the removal of the above viruses An antibody to ribonucleoside or ribonucleic acid. These antibodies may be monoclonal or polyclonal antibodies or may be F (ab7) 2, Fab ', Fab which are fragments of antibodies. Antigens can be viruses such as HIV, ATLA, HBV, deoxyribonucleic acid of this virus, high molecular hormone insulin, thyroid stimulating hormone and so on. Any of the aforementioned different labeled compounds and radioactive isotopes can still be used, although the present invention only illustrates the use of enzymes as labeled compounds. This, dragon body or antigen can be attached to the solid phase material by physical absorption or chemical bonding. The physical absorption is performed by the reaction between the solid phase material and the antigen or antibody in an appropriate buffer. As the buffer solution, phosphate buffer solution, tris hydrochloric acid buffer solution, master salt buffer solution, etc. can be used. The reaction can be completed by mixing and keeping them at a temperature of 4 ° C to 37 ° C for a period of time, preferably at room temperature. The chemical attachment can be carried out by using the carbodimide method in the peptide attachment method. Another chemical method is a method performed in a divalent cross-linking reagent such as glutaraldehyde or cyanutric choride (compare Peptide synthesis method 〃, Maruzen, 1 9 7 5 or ★ Enzyme Immunoassay ", Kyoritsu Shuppan "; ,,, Protein ribonuclease 〃, special publication number 31, 1987). The enzyme-labeled antibody used in the enzyme immunoassay depends on a measured subject and can be recognized by the antibody. The epitope is equal to or different from that attached to the solid phase (please read the precautions on the back before filling this page). Use the China National Standards (CNS) A4 specifications (210x297 gong) -8-199858 Λ 6 Β6 Printed by the Central Standards Bureau of the Ministry of Economic Affairs β Gongxiao F Cooperative V. Invention description (7) Antibody to the material. In addition, for antibody detection, the antibody needs to react to the immune droplet. The bond between the antibody and the enzyme can be obtained by a known covalent or non-covalent bond (compare '' Protein Ribonuclease 〃, No. 3 1, 3 7 to 4 5 pages, 1 9 8 7 years) . Enzyme use includes pervaporase, alkaline phosphatase (Ulkaliphos-Phatase), galactosidase, glucose vaporization enzyme and substrate based on the enzyme used and from ABS, Luminol pervaporation hydrogen for pergasification Compound enzyme, p-nitrophosphate »methylunbelIifenyl phosphare, 3 _ (2-1-pyr〇-tricyc1〇 [3.3-1.13,7] decan-4-methoxy-4- (3 " -phosphonyloxy-phenyl-1, used for age 2-〇11〇-xetane discodium salt (AMPPD) of dish vinease, used for the selection of P_ni trophenyl-〇-galactose of galactosidase. The measurement of color, fluorescence or brightness is detected by a detection device from a Performed in a reaction of 4 degrees Celsius to 4 degrees Celsius. Enzyme immunoassay measurements can be achieved using coloarimetry, fluorescent agents or chemiluminescence. Spectrometers, light counters, etc., or even photographic film can also be used. In addition, possible A method called "acceleration method" is used, in which a measurement is performed when the reagent is heated to a temperature range of 4t: to 4〇t: Although the present invention will be described in detail with reference to the enzyme immunoassay (EIA), it should be noted that The invention can also apply radioisotope immunity Test (RIA) or other methods and correction of certain measurement parts. Used in radioisotope immunoassay, radioisotopes such as iodine 125, iodine 131, shovel 14, tritium, etc., are used as sassafras to replace enzymes. As those used The same process of the enzyme immunoassay is also used in the radioisotope immunoassay (please read the precautions on the back before filling in this page) Binding-Strapping-This paper uses the Chinese National Standard (CNS) A4 specifications (210x297 Public) -9-199858 Λ 6 Β6 Printed by the Beigong Consumer Cooperative of the Central Standards Bureau of the Ministry of Economy V. Invention Note (8) The radioactivity was measured. In this case, the radioactive labeling of antigen or antibody is easily performed By using Bolton-Hunter reagent. For example, it can be prepared by adding Bolton-Hunter reagent to an antigen or antibody solution dissolved in 0.1 M sodium gas silicate aqueous solution, and after 1 to 2 hours, removed without reaction The Bolton-Hunter reagent uses a G-25 desalting column. In addition, 1251 radiolabeling can be easily accomplished by using the chloramine T method or the iododine method. In order to achieve an immune response, The sample is applied to the solid phase material and reacts at 4 to 40 degrees Celsius, preferably at 20 to 38 degrees Celsius, for 1 to 18 hours, washed with saline or distilled water and then calculates its radioactivity. A flash counter is available Measured here. It must be noted that the above process according to the invention can be operated manually for each magazine. Also, the structure of the storage box itself must be included in the scope of the present invention. ♦ BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the external configuration of an automatic enzyme immunoassay device according to the present invention; FIG. 1A is a plan view of a storage box according to the invention; FIG. 1 B is a view of the storage box shown in FIG. 1 A 1C to 1E are cross-sections of other embodiments of the storage cassette according to the present invention; FIG. 1F shows the measurement results using the cassette according to the present invention; FIG. 2 is a perspective view schematically showing the inside of a device Structure; (Please read the precautions on the back before filling in this page) This paper uses the Chinese National Standard (CNS) A4 specifications (210x297 public registration) -10-199858 Λ 6 Beigong Consumer Cooperative, Central Bureau of Standards, Ministry of Economic Affairs Printing 5. Description of the invention (9) FIG. 3 is a plan view of the internal structure of the device shown in FIG. 2; FIG. 4 is a partial cross-sectional view taken along the line IV-IV of FIG. 3; FIGS. 5A to 5C show a The pick-up device of the device; Figure 6A is a cross-section plaque of the ascending mechanism; Figure 6B is a cross-section along the line VI-VI in Figure 6A; Figure 7 shows the construction of a pouring device for pouring the required solution into the storage box Pick up a slice in the required hole through this; 8 is a sectional view of the stirring part; FIG. 9 shows another modification of the unbound separator together with an unbound separator; FIG. 10 is a cross section of the unbound separator shown in FIG. 9; FIG. 11 is a cross section showing stirring Another embodiment of the part; FIG. 12 shows an embodiment of the light measuring part; FIG. 14 shows another embodiment of the light measuring part; FIG. 15 is a plan view of the light measuring part shown in FIG. 14; 16 is a diagram showing the results of the measurement part shown in FIG. 14; FIG. 17 is a plan view of a storage box configurator; FIG. 18 is a perspective view of the storage box configurator; FIG. 19 is a flowchart showing a one-step immunoassay test The method is performed using the device according to the present invention; FIG. 20 is a flowchart showing the two-step immunoassay method using the device according to the present invention; FIG. 21 is a flowchart showing the delayed immunoassay method using the device according to the present invention Implementation; and (please read the precautions on the back first and then fill out this page) This paper uses the Chinese National Standard (CNS) A4 specifications (210x297 mm) -11 ~ 199858 Λ 6 Β 6 employees of the Central Standards Bureau of the Ministry of Economic Affairs Printed by the cooperative Preparation 5. Description of the invention (10) Figure 22 is a flow chart showing a two-step immunoassay method using a diluent and performed using the device according to the invention. ♦ Detailed description of the preferred embodiment Figure 1 is a perspective view of an automatic enzyme immunoassay device according to the present invention. In FIG. 1, the automatic enzyme immunoassay device 1 includes a configuration in which a mask frame 1a has a removable cartridge reservoir 30 in a lower portion thereof. The magazine accumulator 30 accumulates a plurality of magazines 4 in a row and column matrix. An input section 2 includes a push button 2a and a measurement selection button 2b, etc., which are arranged on the side of the mask frame 1a and an output section 3 is arranged in the front panel of the mask frame 1a. A processing section 10 (Fig. 2) is used to perform a series of mixing of the sample with the enzyme marker and the substrate, stirring them, and causing the reaction and measuring the reaction between them are arranged in the upper part of the mask frame 1a. A lotus feeding part is used for lotus feeding storage box and a control part is used to control the operation of the squash row, etc., which is not shown, and is accommodated in the cover frame 1 a. FIG. 2 schematically shows the internal structure of the mask frame 1 a. In FIG. 2, the mask frame includes a lower order and a higher order. The processing section 1 includes, at a higher level, a reaction line 11 includes a pair of parallel endless conveyor belts 71 which are pushed by a step motor and the magazine 4 is sequentially moved along it. A dilution section 25, a stirring section 17, a magnetic separator section 18, a cleaning section 19, an absorption pouring / stirring section 16, a measuring section 20 and an exclusion section 2 1 are arranged along the reaction line 11 in order. A copy of the accumulator 12 is provided at a higher level. It stores multiple samples (please read the precautions on the back before filling in this page). Binding-Binding. The size of this paper is based on the Chinese g-standard (CNS) A4 specification ( 210X297 public splash) -12-199858 Λ 6 Β 6 Printed by the Central Bureau of Standards of the Ministry of Economic Affairs β Industry and Consumer Cooperatives 5. Description of invention (11) 44 and a sheet accumulator 1 3 for storing multiple sheets 1 3 a is also provided The sample accumulator 12 is immediately adjacent in the higher order. The absorption / dispensing pouring part 16 includes multi-value absorption / pouring devices 16a, 16b, and 16c appropriately arranged along the reaction line 11 to attract a predetermined amount of sample to a sheet 13a. With an appropriate pump mechanism, pour it to transfer to In the reaction well of one of the storage cartridges 4 of the reaction line 11, the enzyme marker substance 7b or 7c is absorbed from the enzyme marker well 7b or 7c of a storage cartridge 4 and it is poured into its reaction well to obtain their mixture . The agitating portion 17 accumulates the mixture in the reaction well of the storage box so that the enzyme immune reaction occurs. The stirring section 17 includes a plurality of stirrers 17a and 17b appropriately arranged along the reaction line 11. The magnetic separator 18 includes a plurality of separators 18a and 18b arranged at appropriate positions along the reaction line. ~ The cleaning section 19 includes a plurality of cleaning devices 19a and 19b arranged at appropriate positions along the reaction line. The above part is operated under the control of a control part 5, which has a programming body 2 2 containing programs for different enzyme immunoassays, such as one-step measurement, two-step measurement, delayed response measurement and dilution Two-step measurement of agents. The control section 5 also includes a billion-element 23 for storing information needed to obtain immunization information from an output data of the measuring section 20 and a central processing unit 24 whose one end is connected to the output of the measuring section 2 and in another One end is connected to an output section 3 and an input section 2. The central processing unit 24 controls the operation of the control section 22 itself. The output part 3 may include a plotter and a display (please read the precautions on the back before writing this page). Binding and binding. The paper size is free to use the Chinese National Standard (CNS) A 4 specifications (210X297 mm)- 13-199858 Λ 6 Β 6 Printed by the Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs V. Invention Instructions (12). These above-mentioned components will be explained in detail later with reference to FIG. 2, FIG. 3 is a detailed plan view of the device shown in FIG. 2 and FIG. 4 is a partial cross-sectional view along the line IV-IV in FIG. 3. As mentioned earlier, the role of the storage box itself is very important in the present invention. Therefore, the storage box will first be explained in detail with reference to FIGS. 1 a to 1 e and then its preparation and results will be explained. As shown in FIGS. 1 a and 1 b, the storage container 4 includes a substantially rectangular plate portion 4 a having a notch at the longitudinal end 4 b. These notched ends are used to stabilize the storage box. Therefore, any protrusion can be formed on the plate portion 4a instead of the notch. At least two holes are formed in the rectangular plate portion 4a side by side in the lengthwise direction as shown in FIG. 1c, although the storage case 4 shown in FIG. 1a includes three holes 4c, 4d and 4e. The configuration and depth of each hole slot can be arbitrarily selected depending on the application required. However, at least one of these holes (4c) is made deeper than the other holes, the reason for which will be described later. The well 4c is first filled with a solution containing a solid phase material to which antigen or antibody is attached. The solid phase may be particles or an inner wall thereof which may be used as the solid phase as described above. In order to keep the solution stable, at least the pores 4c can be sealed by a sealing material 4f which can be aluminum foil, polymer film, individually or in the form of an adhesive sheet. The seal 4 f can be broken by an appropriate breaker when in use. Storage 4 can be formed from the resin poly sthylene resin, as previously described. Instead of the notched end 1 〇b, protrusion can also be provided. The changes of the magazine 4 are shown in Figures 1 c, 1 d and 1 e. In Figure 1 C, the storage box 4 (please read the precautions on the back before filling in this page) Packing-Line · This paper standard uses the Chinese National Standard (CNS) Standard 4 (210x297 public issue) -14-Ministry of Economic Affairs Printed by the Central Standards Bureau employee consumer cooperative 199858 Λ 6 _Β_6 V. Description of the invention (13) has two holes corresponding to the holes 4c and 4d in FIG. Ip, which can be used when no dilution operation is required. In FIG. 1 d, the storage cartridge 4 has 3 pores, the middle pore has a minimum depth, and the remaining pores are filled with antigens or antibodies of the same solid phase material relative to the pores 4c in the pore 1 a. This cartridge is suitable for simultaneous measurement of two sera. When these deeper pores are filled with antigens of different solid phase materials, it can be used to measure two objects simultaneously. Figure 1e shows a storage box with 4 holes. This is used to simultaneously measure two objects and the dilution operation. Returning to Figures 1a and 1b, the well 4e is filled with serum or diluent and can be used for reaction or dilution operations and the well 4c is used for reaction in antigen detection or for antibody dilution. Now, the preparation of this storage box will begin with the preparation of a solid phase. I-Storage of the storage cartridge 1-The acidified monostrontium carboxylate particles can be obtained by adding 50 ml of 3-a-minopropyltriethoxysilane to 5 g of ferrite particles (polyethylene has An average core particle size ◦. 3 chemi) which has been previously cleaned 5 times with distilled water every 60 seconds. Using an ultrasonic cleaner (Bat t type, manufactured by Nippon Seiki Seisakusho KK), another 3 cc is added Glacial acetic acid was reacted at room temperature for 3 hours, followed by washing and reaction with s 1 utar ic acid dehydrate. Add glacial acetic acid drop by drop under freezing and stirring, and wash with distilled water, methanol and distilled water every 3 times, and another 5 times (please read the precautions on the back before writing this page) This paper standard is universal Chinese national standard ( CNS) A4 specifications (210x297 public goods) -15-19 & 858 Λ 6 Β 6 Printed by the EX Industry and Consumer Cooperative of the Central Standards Bureau of the Ministry of Economy V. Description of the invention (14) With 0.1 mL of sodium hydrogen per 300 mL Wash with sulfonate solution. The reaction with gl_ utaric acid can be achieved by adding 2.85 grams of glutaric acid dehydrate to 100 ml of 5% weight (0.1M sodium hydrogen monohydrate solution) particles and reacting for 10 minutes. After the completion of this reaction, the mixture was washed 3 times with 0.1 M sodium hydrogen hydrogenate solution per 300 ml, and distilled water was used 5 times, which was used as carboxylated ferrite particles. 2-due to the phase: carboxylated iron ferrohydride with anti-TS Η antibody particles in 5 ml of 20 mM phosphate buffer (pH 4.5) to disperse 5 ◦ mg I-1 prepared carboxyl Acidify the ferrite particles, and then add 5 ◦ mg of water-soluble diimine. After reacting at room temperature for 20 minutes, the surface float was removed, and 5 ml of anti-TSH mouse I gG antibody solution (1 mg / ml, 0.002M phosphate buffer, pH: 4.5), And this mixture is stirred by the end of the blender. After 2 hours, the particles were washed 5 times with 2% BSA solution (◦. 1M hydrogen trichloride (Tris-HCP), ImM magnesium chloride, pH: 7.5) and dispersed in a similar BSA solution to obtain anti-TS Η —Mouse I sG antibody sensitivity carboxylated ferrite particles. 2-In-phase: Anti-TSH combined with the surface of the trough groove-mouse IrG JJ-buckle. In the first wall 10b of the storage box 10 in FIG. 1b, 200 μl of anti-TSH-mouse I gG antibody solution (4 emblems / (please read the precautions on the back before filling in this page) Binding · Threading · This paper uses the Chinese National Standard (CNS) A4 specifications (210x297 mm) -16-Economy Printed by the Consumer Cooperative of the Central Bureau of Standards of the Ministry of Agriculture 199858 Λ 6 ____ Β 6_ V. Description of the invention (15) ml, 10 mM phosphate buffer, acidic value 7. ◦) was poured and maintained at room temperature for 18 hours. The wells were cleaned 3 times with physiological saline solution and then 300 μl of 2% BSA solution (0.1 M trigasified hydrogen (Tr is—HC5), 1 mM magnesium chloride, pH 7.6) was added to it, resulting in A well-slot storage box is combined with anti-TSH-mouse-Ig G antibody solution. 3—Solid phase: 100 polyethylene drops at 1/8 of anti-TSH-Mouse-Tg G antibody combined with polyethylene particles were immersed in 25 ml of anti-TSH-Mouse-IgG antibody solution (4 μg / ml, 10mM phosphate buffer) and maintained at room temperature overnight. These drops were washed 3 times with physiological saline solution and then 25 ml of 2% BSA solution (same as above 1) was added to it to obtain polyethylene-conjugated anti-TSH-mouse-Ig G antibody solution. I. The storage cartridge for TS Η measurement of the most prepared 1 a small storage cartridge 25 ◦ microliters of anti-TSH-mouse-I gG antibody binding ferrite particles prepared in I-2 (0. 04% particles) was poured into the well 4c of the storage box 4 in FIG. 1b and 1◦0 μl of alkaliphosphatase (alkalinephosphatase) was added with anti-TS H—mouse—I g G—F ab anti-skull solution ( Contains 0.1M hydrogen trichloride (Tr is — HCi? (Please read the precautions on the back before writing this page). Packing and threading. The size of this paper uses the Chinese National Standard (CNS) A 4 specifications (210x297 gong)- 17-199858 Λ 6 Β6 Printed by the Employee Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economy V. Invention Instructions (16)), 0 · ImM zinc chloride, ImM magnesium oxide, pH 7.5, 2% BSA, 5 0 0 ng / ml alkaliph-osphatase (anti-τ SH-mouse-Ig GF ab antibody) was poured into the second well for 4 days. The holes of these cartridges are covered by an aluminum foil with a polyethylene-based vapor overcoating surface and heat-sealed. The resulting storage cartridge was used as a particle-type T S H measurement storage cartridge. 2 —Wall-type casket 10 ° withdrawn alkaline phosphatase added anti-TSH —mouse-I gG-Fab antibody solution (containing ◦.1M hydrogen trichloride, 0.1 mM vaporized zinc, 1 mM magnesium chloride, pH value 7. 5, 2% BSA, 500 milligrams / ml phosphatase plus anti-TSH mouse IgG_Fab antibody) was added to well 4d, which contains anti-TSH-mouse-I gG antibody prepared in I 1_1. The storage box is heat-sealed by an aluminum foil with an attached surface covered with polyethylene vapor. 3- The drop-shaped pan-feather box prepared one of the anti-TSH-mouse-I gG antibody and the polyethylene drop in 1_1 was placed in the well 4 c and 2 50 B 2% BSA solution withdrawn was added to it on. Then, 1 ◦ liter of alkaline phosphatase bound anti-TSH-mouse-IgG-Fab antibody solution (contains ◦.1 M hydrogen trichloride, ◦. ImM chlorinated bell, ImM chlorinated ϋ, acid age 7 . 5, 2% BSA, 500 mcg / ml alkaline phosphatase bound anti-TSH mouse IgG Fab antibody) was poured into the well 4e. (Please read the precautions on the back before filling out this page) The paper size is free to use Chinese National Standard (CNS) A4 specifications (210x297 male dragon) -18-Printed by Beigong Xiaozhi Cooperative of Central Bureau of Standards, Ministry of Economic Affairs 199858 Λ 6 ____ Β6_ V. Description of the invention (17) The storage box is heat-sealed by an aluminum foil with a polyethylene-based vapor cover and an attached surface. Preparation of Hi — ρ cartridge 1-HTLV-I antigen ferrite particles can be obtained from Nippon Paint Κ · Κ. It is dispersed into 800 μl of 10% content 2 ml, and HTLV- I antigen (4 μg / ml) was added to it, followed by stirring at room temperature overnight with a capped stirrer at one end. The particles were washed with 2% BSA solution (◦. 1Μ trigas, ImM chloride, pH 7.5) 5 times and dispersed in the same BSA solution to obtain HTLV-1 antigen bound to ferrite particles . ~ IV — used for Η TLV — the preparation of the storage gate for antibody detection combined with the preparation of the iron salt solution in Π — 1 of 3 5 ◦ microliters of Η TLV-I antigen (0.008% / particle / BSA solution) was poured into well 4c and 300 μl of anti-human-IgG-mouse-I gG antibody binding alkaline phosphatase was poured into well 4e. The storage box is heat-sealed with aluminum foil. V — The measurement of TS Η in the holes 4 c, 4 d and 4 e is broken by the seal breaker and the sample contains 50 μl of TSH (◦, 1◦ U / mL) (please read the back Please fill in this page again for more information) Binding and Strapping. This paper is printed in China National Standards (CNS) A 4 specifications (210x297mm: ¢) -19-199858 Λ 6 Β6 Printed by the Employee Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (18) and 50 microliters of anti-TSH Fab / antibody supplemented with phosphatase single cell binding (single cell binding content 0.5 micrograms / ml, 0.1 M trigas, 2% BSA, ImM Magnesium chloride, 0.1 mM vaporized zinc, pH 7.5) contained in the well 4c is added to the well 4d and mixed. 1 One-drop type T S Η measurement of the halo hole. After 10 minutes, 30 liters of the mixed liquid contained in the hole 4c is added to the hole 4d containing the drop and stirred. After 1◦ minutes, the surface float was removed by suction and washing 4 times with physiological saline solution. 3 0 ◦The withdrawn substrate solution containing 100 gram / ml of AMPPD (0.1 M tri-state gasified hydrogen, luM gasified magnesium, 0.1 mM zinc oxide, pH 9.8) was added and Allow to react at room temperature. Ten minutes after the reaction, the reaction was measured with a photometer (Aroka K.K.). The results are shown in Figure 1f. 2-Wall type T S Η Measure the consumption of the most wells. After 10 minutes, 30 microliters of the mixed solution contained in wells 4c was added to wells 4d with additional antibodies and stirred. After 10 minutes, the surface float was removed by suctioning and washing 4 times with physiological saline solution. 300 μl of AMPPD solution was added to well 4c in V-1 and allowed to react at room temperature. Then, after 5 minutes, the reaction was measured by photometer. The results are shown in Figure 1f. (Please read the precautions on the back before writing this page) Line · This paper uses the Chinese Standard (CNS) A 4 specifications (210 father 297 male; 4 ·) -20-Bei Gong, Central Bureau of Standards, Ministry of Economic Affairs Printed by Consumer Cooperatives 199858 A 6 __B6_ V. Description of the invention (19) 3 —Drop-type TS Η measurement of the perforation hole after 1◦ minutes, 30 μl of the mixed solution contained in the perforation hole 10c is added Go to the well containing the antibody-bound particles, stir and set for 10 minutes as before. The hole 4c is faced with a permanent magnet whose surface magnetic field is 3,000 Gauss to attract particles. The surface float is removed by suction and, after pouring the physiological saline solution into the well 4c and removed, the ferrite particles are attracted by the same magnet and the surface float is removed by injection. This process is repeated 4 times. 300 microliters of AMPPD was added to the well 4c in V-1 and allowed to react at room temperature for 5 minutes and then measured with a photometer. The results are shown in Figure If. VI—Measurement of HTLV-I anti-skeleton using HTLV-l I wells. The seal on well 4 c was broken by a seal breaker and 20 μl of serum was added to it. In addition, 180 μl of diluted solution (◦. 1M hydrogen trichloride, 1 mM vaporized magnesium, ◦. 1 mM vaporized zinc, pH 7.0 containing 10% NRS, 2% BSA) was added to it. 2 ◦ Microliters of diluted serum is mixed with HTLV-1 antigen additional particles in the well and placed after stirring for 10 minutes at 37 degrees Celsius as before. The hole 4d faces a permanent magnet with a surface magnetic field of 300 ◦ Gauss to attract particles. The surface float was removed by suction and 400 µl of 4% physiological salt solution was added to the well 4c and stirred. Ferrite particles are attracted by the same magnet and surface floats are removed by suction. This process is repeated twice. 25 ◦Microliters of anti-human body _ I gG antibody binds to I gG base too K / i free Ψ ® ffi Ai find m (CNS) 掩 格 (210x297 male 綮) -21 ~ (please read the note on the back first Please fill out this page again) < Order _ line-199858 Λ 6 ___ Β6 _ V. Description of the invention (2C)) Phosphatase solution (3 0 ◦ng / ml protein solution) was added to well 4c and placed as described above for 10 minutes. The hole 4c faces a permanent magnet whose surface magnetic field is 3000 Gauss to attract particles. The surface floats were removed by suction, and then 400 liters of .4% physiological saline solution was added and stirred. Ferrite particles are attracted by the same magnet and surface floats are removed by suction. This process is repeated 4 times. 300 μl of AMPPD was added to the well 4 c in V_1 and allowed to react at room temperature for 5 minutes and then the brightness was measured by photometer for 5 seconds. . The results are shown in Table 1. (Please read the precautions on the back before writing this page) Binding · Threading < The Ministry of Economic Affairs Central Standards Bureau 工 工 消 # Cooperative society prints too M m + due to excessive housekeeping (4 quasi-m Γι 佂 297 public goods) -22-199858 Λ 6 Β6 V. Description of the invention (21) Ministry of Economic Affairs Printed by the Employee Consumer Cooperative of the Bureau of Standards, 1 Measured sample count of Η TLV-I antibody (X 1 0 = 丨) (count / second) 1 〇.〇〇5 2 0. 〇1 1 Buffer only 3 0 〇0 9 4 〇. 0 〇5 5 0. 〇〇8 1 〇. 〇4 2 negative serum 2 0. 0 5 9 3 〇. 0 5 4 ~ 4 0. 〇6 3 1 〇. 5 9 9 positive Serum 2 〇. 5 3 5 3 〇. 5 4 2 VH — Measurement of CA 1 9 _ 9 1 — Preparation of CA 1 9 — 9 antibody binding particles (please read the precautions on the back before filling this page) . Line. 199858 The Ministry of Economic Affairs, Bureau of Standards, Industrial, Industrial and Commercial Cooperation, Du Printing, A 6 B6 V. 4 Ming # 1 ^, the anti-CA19-9MCA-sensitized ferrite particles were prepared to react with 2 mg of anti- 5 CA19_9 Monoclonal Strip Antibody (MCA) and wash it thoroughly (◦. 004% particles / 2% BSA, 0.1M hydrogen trichloride, ImM magnesium vapor, 0.1mM zinc chloride, pH 7.5 ). 2—The 250-liter anti-CA1 9-9—Mouse—I gG anti-skull-sensitized ferrite particles used in the storage box for the particle-type CA19-9 test were added to the hole of the storage box 4 in FIG. 1c. 4c and 350 μl of alkaline phosphatase-sensitized anti-CA 1 9 — 9-mouse-I g G — Fab antibody solution (5 mg / ml) was added to the well 4d. The storage box is sealed with a PET laminated aluminum foil. 3 — C A 1 9 — 9 Viewing using the aluminum seal in V I-2 was previously broken by a seal breaker and 20 μl of serum was added to the well 4 c and placed as before for 1 ◦ minutes after stirring. Then, the hole 4c faces a permanent magnet with a surface magnetic field of 300 ◦Gauss to attract particles. Surface floats are removed by decantation, and then, 0.2% physiological saline solution is added and mixed. Ferrite particles are attracted to the same magnet and surface floats are removed in a similar manner. This process is repeated twice. Then, 250 liters of labeled antibody solution was added to well 4c in well 4d and stirred. After 1◦ minutes at room temperature, the ferrite particles are attracted and the surface float is removed. This process is repeated 4 times. Then, 300 microliters of the same substrate solution was added to the IV and stirred. (Please read the precautions on the back before filling in this page) < Order-Line · Taishenchichi ii m Ψ ® s ^: 捸 iMCNS) 4 pounds (21 Οχ297 public repair) -24-199858 A 6 B6 V. Description of invention f3) _ Room temperature 5 minutes , Use a photometer to measure the brightness for 5 seconds. The results are shown in Table 2. Table 2 CA 1 9-9 measured serum sample count (X 1 0 3) CA 1 9--9 (count / 5 seconds) (U / mL) 1 0 .2 0 8 1 .9 2 1 .4 0 8 1 9 .3 3 4 .5 6 〇5 9 .5 4 2 .1 4 4 3 1 .6 5 8 .5 7 5 10 8 .9 (please read the precautions on the back before writing this page) · V JI printed by the Ministry of Economic Affairs, Central Standards Bureau, M Industry and Consumer Cooperatives-used for grain-type C: A 1 9-9 standard value of the storage box for measuring _ 25 ◦Certificate is prepared for anti-CA 1 in VI-1 1 9 — 9 — Mouse I gG antibody-sensitized ferrite particles were added to the wells 4c and 4c of the storage box 4 in FIG. 1 d and 350 ml of alkaline phosphatase-sensitized anti-CA19 — 9 mouse IgG — Fab antibody solution (0.5 μg / ml) was added to the well 4 e. These holes are heat sealed with a PET laminated aluminum foil. 1 Measurement of CA 1 9 — 9 The aluminum sealed in V Μ was pre-broken by a seal breaker and every 2 ◦ microliters of different serum was added to the wells 4c and 4c and mixed at the stirring line_ 199858 A 6 B6 Five S 0 minutes. Then, the holes and grooves face a permanent magnet with a surface magnetic field of 3000 Gauss to attract particles. The surface float was removed by decantation, and then 0.2% physiological saline solution was added and stirred. Ferrite particles are attracted to the same magnet and surface floats are removed in the same way. Here the reason is repeated 2 times. Then, 250 liters of labeled antibody solution was added to wells 4c and 4c in well 4d and stirred. After 1 ◦ minutes at room temperature, the ferrite particles are attracted and the surface float is removed. Add 4◦ ◦ of cleaning solution and stir and ferrite particles are attracted again by the same magnet and the surface float is removed. This process is repeated 4 times. Then, 300 microliters of the same substrate solution used in IV was added and stirred. After 5 minutes at room temperature, measure the brightness with a photometer for 5 seconds. The results are shown in Table 3. Table 3: CA19 — 9 test-Sample storage box hole slot sample number count (X103) (count / 5 seconds) (please read the precautions on the back before filling in this page) Packing * Stranding_ Ministry of Economic Affairs Bureau of Standards Employee elimination cooperation Du Yinqing • νί blood 12 3 8 2 6 1X 2 2 8 4 * ο 〇4 5 6 〇〇〇6 3 2 4 1 5 8 6 9 -26-199858 A 6 B 6 Ministry of Economic Affairs Preparation of the F 'Deer Sensitized Ferrite Particles by the Mongong Consumer Cooperative Society of the Central Bureau of Standards. Ferrite particles can be obtained from Nippon Paint KK. It is dispersed in 800 μl of 5% content and 20 ◦ ml of HBs antigen ( 400 μg / ml) was added to it, followed by mixing at one end with a lid-top stirrer at room temperature overnight. The particles were washed 5 times with 2% BSA solution (0.1M hydrogen trichloride, lmM vaporized magnesium, pH 7.5) and dispersed into the same BSA solution, resulting in HBs antigen-sensitized ferrite particles. The storage of particle plastic HT LV-I and HB s antibody detection cartridges was prepared 350 μl HTLV-I antigen-sensitized ferrite solution (0.008% / particle / BSA solution) prepared in M was poured In FIG. 1 e, the well 4c of the storage cartridge 4 and 350 liters of HBs antigen-sensitized ferrite solution (0.008% / particle / BSA solution) are ready to be added to the well 4d in IX. Then 30 ◦ liters of anti-human-IgG-mouse-IgG-antibody-sensitized alkaline phosphatase was poured into the wells for 4 days. The storage box is heat sealed with aluminum foil. XI II Η TLV — I is the measurement of HRS. The seals on the storage slots 4c, 4c 4d and 4 d ** prepared in V are sealed by the seal breaker and 2 ◦ microliter of serum is added to Hole 4d ~. In addition, 180 microliters of diluted solution (◦. 1M hydrogen trichloride, 1 m Μ Magnesium chloride, 0.1 m Μ zinc chloride, the pH value is too earthworm chromium chrysanthemum trapped in Wenzhou Huai (CNSWMtU 柊 (:> 10 (297 public goods) -2Ί-(Please read the precautions on the back before filling out this page) Binding · Threading · 1θ9858 5. Description of the invention (26) ^ ^ 7.0 contains 10% NRS, 2% BSA) was added. Every 20 microliters of this diluted serum is mixed with the HTLV-1 antigen-sensitized particles in well 4c and the HBs antigen-sensitized particles in well 4c. After stirring, these wells are placed as before in Celsius 37 degrees for 10 minutes. Then, these holes face a permanent magnet with a surface magnetic flux of 3000 Gauss to attract particles. The surface floats are removed by decantation, then, add 4% physiological saline solution and stir The ferrite particles are attracted by the same magnet and the surface floats are removed in a similar manner. This treatment is repeated twice. Every 250 microliters of anti-human IgG-mouse-IgG antibody-sensitized alkaline phosphatase solution (3 0 0 ng / ml protein solution) was added to wells 4c and 4c / and placed as before for 1◦ minutes. Ferrite particles Once again attracted by the same magnet and the surface float was removed. This treatment was repeated 4 times. Then, 300 μl of the same AMPPD solution in V-1 was added and stirred. After 5 minutes at room temperature, the photometric The brightness is measured for 5 seconds. The result is shown in Table 4. (Please read the precautions on the back before writing this page) Binding and Threading. Printed by the Ministry of Economic Affairs Central Standards Bureau Beigong Consumer Cooperative Society. Guohuai (CNS) public goods) -28-^ 99858 A 6 B6 77 V. Description of the invention 0 /) Table 4 HTLV-I and HBs antibody measurement sample count (X103) count / 5 seconds) Well 15 (HTLV -I) Hole slot 16 (HBs) Printed by Beigong Consumer Cooperative of Central Bureau of Standards, Ministry of Economic Affairs 1 0 0 0 0 6 0. 0 〇2 2 0. 0 1 7 〇. 0 0 9 Buffer only 3 0. 0 0 6 0. 0 1 2 4 0. 0 0 9 0. 0 0 6 5 ◦. 0 1 5 0. 0 0 7 1 0. 0 5 2 0. 1 2 5 Negative serum 2 0. 〇7 2 0. ' 1 3 2 3 0. 0 5 9 0. 1 1 5 4 0. 0 7 8 0. 1 3 1 1 0. 7 2 6 0. 9 2 6 positive serum 2 0. 7 1 8 12. 8 2 1 3 1. 5 2 6 8. 6 4 3 Prepare the appropriate storage box for use in this device as instructed. Now, the device will be explained in detail with reference to FIGS. 3 to 17. (Please read the precautions on the back before filling in this page) Pack · Line · -29-199858 Printed by the Consumer Standardization Cooperative of the Central Bureau of Economic Affairs A6 B6___ V. Description of Invention (28) Multi-storage storage The cartridge 4 storage cartridge accumulator 3 1 in the row and column matrix is movably inserted horizontally into the lower-order part of the device in FIG. 3. Model of the casket transfer mechanism As shown in Fig. 3 and Fig. 4, a storage box transfer mechanism is arranged above the storage box accumulator 31. This mechanism extends along the insertion direction of a magazine accumulator 31 and includes a pair of rails 2 2 1 that are arranged perpendicular to its extension direction and a weight arm 2 2 0 that is movable along the rails 2 21. A magazine pick-up device 3 3 is mounted on the arm 2 2 0 and can move along it. A mechanism for moving the wall 220 along the rail 221 and moving the pick-up device 33 along the wall 220 can be applied to any known mechanism such as the X-Y imager. In this embodiment, the application of this mechanism can be arranged in a known manner by using reversible horses (not shown), pulleys (not shown) and wiring. These reversible motors can be controlled by an appropriate control mechanism to move the pick-up device 33 to a preset position (denoted by A in FIG. 3) and are therefore arranged in the X-Y matrix on the magazine 4 of the magazine accumulator 31 Can be moved to this position by a value. Pick up 婘 詈 The pickup device 33 is shown in detail in FIGS. 5A to 5C. The pickup device 33 includes a vertically movable hook device. Figure 5A is a front view of a hook device /? 3 leisure 屮 8! Sleepy Xuan Jinjin ((:) 4 in the grid (210 297 priced) -30-(please read the precautions on the back first (Fill in this page) Installed-199858 Λ 6 Β 6 Printed by the Employees ’Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs V. _Ming Instructions (29) The picture shows the position on a fe. It is moved down to grab a storage box 4 The opposite end is shown in Fig. 5B. Fig. 5C is a side view of a pick-up device 33. In Figs. 5A to 5C, the pick-up device 33 is moved to a position where a selected magazine 4 is configured while keeping the hook device In the state shown in FIG. 5B and when the pick-up device 3 3 reaches the storage box 4 on the storage box accumulator 3 1, its hook device is further lowered to grasp the storage box and then move to the preset position A. At position A, The pick-up device 3 3 is further lowered to place the magazine 4 in the preset position A. The pick-up device 3 3 includes a generally C-shaped frame 3 2 1 which slidably engages the arm 320 and a pair of vertical rods 322, which are 322 is provided parallel to the opposite end portions of the C-shaped frame 321. A sliding portion 323 is slidably mounted on the rod 322. As shown in FIG. 5C, one side A groove 3 24 is formed in the rear side of the sliding portion 3 2 3 and a motor 3 24 is fixedly mounted on the frame 321. One end of the arm 325 is fixedly connected to a shaft of the motor 3 24 and the other end of the arm 3 25 forms a protrusion 3 2 6 It is slidably fitted in the side groove 324. Therefore, when the horse 324 rotates, the protrusion 326 of the arm 325 slides along the side groove 324, so that the sliding portion 3 2 3 is pushed vertically. A plate portion 3 2 7 is tightly fixed to There is a proper gap between the front part of the sliding part 3 2 3. The gap is given by the pins 3 2 8. A pair of cam levers 3 2 9 are arranged between the sliding part 3 2 3 and the plate part 3 2 7 so that the lever can be placed in the tube Shake around the feet 3 2 8. A pair of hook parts 3 3 〇 are mounted on the front surface of the board part 3 2 7 rotatably around the pin 331. The hook 33 〇a is formed on the hook part (please read the note on the back first Please fill out this page again.) Binding-Line · 199858 A 6 B6 Printed by the Ministry of Economic Affairs + Central Bureau of Standards and β-Consumer Cooperative Co., Ltd. V. Description of Invention (3Q) 3 3 0 The lower part of the upper part and its upper part are rotatable The lower end portion of the connecting cam lever 3 2 9 passes through a hole 333 formed in the plate portion 3 2 7 so that it Each is rotatable near the pin 332. Hook elements 3 3 ◦The springs 34 are offset inward from each other as shown in FIG. 5A so that the right side of the cam lever is deflected counterclockwise. To maintain the hook element 330 shown in FIG. 5A In this state, the clockwise movement of the cam lever 329 is each restricted by the stopper 335. When the sliding member 330 is lowered by the rotation of the motor 324, the hook member 330 is lowered as shown in FIG. 5A. When the sliding member 323 is lowered by more than one degree where the lower end of the cam lever 3 29 contacts the lower side of the frame 321, the lower end portion of the cam lever 329 moves inwardly by the lower side of the frame 321. Therefore, the hook members 330 are turned away from each other to open the hook 33a against the biasing force by the spring 334. Therefore, the storage box 4 can be grasped as shown in FIG. 5B. Therefore, when the sliding element 323 moves upward, the storage case is lifted upward with the help of the hook 330a and the spring 334. In this way, the pickup device 3 3 holding the storage box 4 is moved to the preset position A shown in FIG. 3 by the crane mechanism and then the pickup device 3 3 is lowered again so that the storage box 4 can be borrowed from the cam lever 3 2 9 under the hook The lower end is in contact with the lower side of the frame 321. Next, the pickup device 33 returns to the lower value position of the magazine accumulator 31. The parallel lift mechanism 3 2 is used to move the crane through the construction of the lotus in the lower stage. It is recognized in the lower stage (R cold Li 冮 κ sriieSiCNS). 4 Shao Yi: Π0χ: 297 public funds) -32 _ (please first Read the precautions on the back and fill in this page) Packing-Ordered by the Ministry of Economic Affairs, Bureau of Standards, Beigong Consumer Cooperative Printed by 199858 A 6 _B6 V. Invention description (31) The storage box 41 rises to a higher level and then goes to a reaction line . Therefore, the lifting mechanism 32 is arranged at the position A. 6A and 6B are cross-sectional views along the line VI-VI in Fig. 6 showing the lift mechanism 32. Figs. In FIGS. 6A and 6B, the mechanism 32 includes a straight frame 406 having a vertical groove 409 in its front wall, a reversible horse 405 (FIG. 6B) disposed outside the frame 406, and a pair of vertically arranged wheel 401 The fixed configuration is in block 406. One of the key wheels 401 is connected to a shaft of the motor 405 so that a wheel 4 ◦ 2 can be pushed on the wheel 401 in the reverse direction to thereby be within a limited range as shown in FIG. 6A. A sliding block 4 ◦ 8 is covered by the frame in a frame 4 0 6 that can slide vertically and has a side groove 4 1 1 that opens to the front wall of the frame 406. An arm 404 is slidably received in the side groove 411. The rear end portion of a cross arm 404 is rotatably connected to a position 41. On the key 402, when the slider 408 is at the lowest position in the frame 406, the arm 404 is fully retracted and, after passing the highest position in the frame, The arm is fully retracted as shown in Figure 6A. In detail, the front part of the arm 404 extends on the frame 406 through the vertical groove 4 ◦ 7 and is equipped with a pickup device 33 / which is similar to the pickup device 33 of the lotus delivery mechanism. The reversible motor 405 reversibly pushes the sprocket so that the chain 402 reciprocates within the limits between the positions B and C of the connection point 41 of the rear end of the 402 and the cross arm 404. Therefore, the front end of the arm 404 is along a line in FIG. The trajectory shown by the dotted line 500 moves. That is, in Fig. 6A, the fully retracted arm 404 is moved to the position of the upper sprocket by the moving key wheel 401 in the direction of the arrow. Then, after passing the upper quarter circle along the upper wheel 401, the cross arm 404 moves downward and gradually protrudes and, finally, it is finished (please read the precautions on the back before filling this page) Order _ Line-Tai Chi Zeleng am Φ a κ Wen Xuanhuai (CNS) A 4 Button C10 X 297 (Public Football) -33-Printed by the Beigong Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs 1998Κ «_Be_ The last four of the round One-half circle moves. The semicircular trajectory of the moving upper end portion of the front end of the cross arm 404 and the pick-up device 3 3 > are therefore important in view of the stable translation of the magazine onto the reaction line 11. The picking and releasing operations of the pick-up device 33 / correspond to the magazine 4 and are the same as those described in relation to FIGS. 5A and 5B. That is, in the lower position of the arm 404, the sliding member is lowered to grasp the storage case and then move upward. Then, the device 33 moves along the dotted line of the track 500 together with the arm 404, and at the end of the track 500, the sliding element is lowered again to release the magazine onto the reaction line 11. I. Structure of the upper-stage sampler section As shown in FIG. 3, a sampling cassette 12 and the same local cassette 13 are arranged in a second, upper stage. The sampling cassette 12 includes multiple sampling pieces 44 arranged in a horizontal plane and the sample cassette 13 includes a plurality of sample containers 13a, each of which contains a sample containing a substance to be measured, arranged in a plane. The anti-lulu 1 1 reaction line 11 extends substantially at a lower order in a direction perpendicular to the insertion direction of the magazine accumulator 31. The reaction line 11 includes a pair of parallel endless belts 71 as shown in FIGS. 2 and 3. The endless belts 7 1 each support the opposite end portion of each storage cassette 4 so that the storage cassette can be stably moved along it. The endless belt 71 is driven by a roller 72 which is arranged at the opposite end portion of the reaction line 111. The roller 72 is alternately pushed by a step motor so that it is placed on the reaction line (please read the notes on the back before filling in (This page) -34-199858 Printed by the Beiliang Consumer Cooperation Department of the Central Liangzhun Bureau of the Ministry of Economic Affairs. 5. Description of the invention (33) The storage box can be stepped for a period of time, such as 30 seconds. The magazine 4 raised by the lifting mechanism 32 and placed on the starting portion of the reaction line 11 is stepped to the next position on the reaction line 11 after 30 seconds and this is repeated until a measurement is completed. There are many devices arranged along the reaction line 11 to generate a desired reaction. Such a device will be described in detail later. Close shot breaker As described above, the storage box 4 is placed at the starting point of the reaction line 11 and has a hole sealed by a sealing film 11f. In order to remove this seal, a seal breaker 40 is provided above the reaction line 11 at the position of the starting point of the phase. In the illustrated embodiment, the seal breaker takes the form of a square with a lower surface formed and a plurality (in this case, three) projecting downward so that, by lowering the square, in each hole of the storage box The part of the sealing film 11f in the middle is broken by the protrusion to make these holes usable. Because the design of such a block is arbitrary and those skilled in the art can easily design it, this detail will not be explained. The sample moving mechanism is shown in Figs. 2 to 4, the same lotus feeding mechanism is provided on the upper stage, which has a structure substantially the same as that of the magazine transport mechanism except that a sampling pump unit 8 2 is installed in The pick-up device 3 3 is replaced on the arm 81. In the rail 80, the arm 81 can slide 8 ° along the rail and the sampling unit 82 mounted on the arm 81 can move along it. The movement of the pump unit 82 is on a plane (please read the precautions on the back and then fill out this page) Order 'line _ Taifan select Rm 屮 @ 3let it strontium 4 yards door 10〇 297 public loan) -A 6 B 6 199858 Middle five husband ϋ black € i set 3 3 same. (Please read the precautions on the back before filling in this page) The defeated pump unit Sampling unit 8 shown in Figure 7 2 includes a nozzle 8 2 1 and a pump part 8 2 2 are arranged in a box 8 3 and Connected to each other by a suitable tube 8 24. The nozzle portion 821 includes a nozzle 823 which is secured to a plate 825 which is vertically movable by, for example, a solenoid. When the nozzle 8 2 3 is lowered, a tip 44 of the nozzle is engaged in the sampling cassette 12. Then, it is raised and moved to bring the sheet 44 to an appropriate position where the pump portion 8 2 2 is activated to attract a liquid contained therein and then moved to another position to pour it out. Later, move to a position d (Fig. 3) to arrange the used sheets into the sheet dispenser 70 °. Sowing and mixing parts and no Dongbeng separator. Printed by the Employee Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs. In FIG. 10, which is a cross-sectional view of an agitating portion, a rod 501 has a shaft centrifugally connected to a motor 504 at one end and a U-shaped member 502 at the other end. The middle part of the rod 501 is elastically supported by a supporter 503. The U-shaped element 5 ◦ 2 is adjusted to properly receive the first hole of the storage box 4 sent by the loop belt 7 1. When the motor 504 rotates, the rod 50 1 is thereby vibratedly pushed to vibrate the U-shaped member 502 so that the first hole received therein is vibrated to stir its contents. In FIG. 9 it is a plan view showing the modification of the stirring part shown in FIG. 8, a beam 50 04 is secured to the middle part of the rod 50 1 and the rod 50 1 has one end centrifugally connected to a motor shaft and the other is too R iA ffl Φ S a -iat (CN'S) ¥ 4 twisted public loan) -36-199858 A 6 B6 Printed by Beigong Consumer Cooperative, Central Bureau of Standards, Ministry of Economic Affairs ^ 503 / flexible support. A pair of bars 50 1 a and 50 1 b extend from opposite ends of the beam 504. U-shaped elements 502a and 502b are attached to the ends of the rods 50 1 a and 50 1 b, respectively. Between the U-shaped elements 502, a magnetic unbound separator 90 is arranged. The unbound separator 90 includes a permanent magnet 9 2 supported by a magnetic element 9 1 on one side of a channel disposed in the first hole of the storage box 4 as shown in FIG. 10. By passing through the magnet 92, the magnetic particles therein are attracted to the wall of the hole groove of the storage box and, by cleaning the hole groove with an appropriate cleaning solution, free antigen or antibody can be removed. Figure 11 shows another embodiment of the stirring section. In this embodiment, a large cylindrical element 618 has a relatively large material specific gravity and has a blind hole 6 2 0 and a cam ramp 6 2 2 formed in a wall of the cylinder by cutting. A plug element 614 is inserted into the blind hole 620. The plug member 614 has a blind hole where the shaft of the straight 610 is firmly inserted. The plug 61 4 has a protrusion 6 16 which follows the cam ramp. At the bottom of the blind hole 6 2 0 of the cylinder 6 1 8, a centrifugal hole 6 2 4 is formed so that the pin 6 2 6 is fixedly inserted. A slot receiver element 628 can be rotatably supported by a bracket 6 2 7 through an exposed portion of a pin 6 2 6. The slot receiver element 628 has a cavity in which the slot is received. Due to the weight, the cylindrical element 618 tends to fall off due to gravity. Therefore, in non-operation, it is completely lowered so that the protrusion 616 of the plug 614 contacts the uppermost position on the cam ramp 622. When the motor 610 rotates counterclockwise, the plug 614 is rotated counterclockwise, so that its pin 616 pushes the cylinder 618 upward along the cam ramp 622. When the cylinder 6 1 8 reaches the top position (please read the precautions on the back before filling out this page). Order < Too stubborn and unreliable because of its presence (CNW4 掗 格 ΓΠ0Χ297 public interview) -37-199858 A 6 B6 Printed by the Beigong Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs V. Description of invention (36) At the hole receiver 628 receiving the hole, the cylinder 618 rotates counterclockwise to keep the position relative to the hole closed as before. Because the receiver 628 is slightly centrifuged with respect to the cylinder 618, the receiver 628 is vibratingly rotated, so that the contents of the slot are mixed. Fig. 12 shows another embodiment of the stirring part. In FIG. 12, the straight 6500 is placed between the belt 71 in a way so that it can be moved vertically by, for example, a cam element 65.2 mounted on a horizontal axis 654 and in contact A bottom of the motor 6 5 0. On a shaft of the motor, a slot receiver 6 5 6 is rotatably mounted through a bracket 6 5 8 in a centrifugal manner. In the upper position of the motor, the slot receiver can receive the bottom portion of the storage slot 4c of the belt by the belt 71, and as the horse moves further upward, the slot absorber pushes the storage box upward. When the magazine is pushed substantially upward, it adjoins the magazine guide 6 6 0 formed on a lower surface of a supporting member 6 6 2 in a position relative to the recess of the magazine. The vertical movable range of a supporting member is restricted by its side pins 6 6 4 engaging the vertical grooves 666 formed in the substantially reverse U-shaped frame 6 6 8. Between the support and the top portion of the frame, a fulcrum element 670 is provided, which has a lower end directed to a hole or recess 672 formed in the upper surface of the support element. The fulcrum element is deflected downward by a spring 6 7 4 to thereby deviate downward from the support element. When the motor moves upward to the uppermost position by the crank element, it is energized to centrifugally rotate the orifice receiver to thereby stir the contents of the orifice. In this case, because the supporting element stably supports the upper part of the storage box, the centrifugal vibration motion of the hole-slot receiver can be effectively transmitted to the hole-slot, resulting in fully stirred chopsticks.漼 iCNSVH Unloading QlOy 297 Gongyu) -38-(Please read the precautions on the back before writing this page) Packing-Order _ Line-199858 Λ 6 Β6 Printed and invented description by the employee consumer cooperative of the Central Standards Bureau of the Ministry of Economic Affairs ( 3) When more such mixing parts are arranged along the reaction line, the straight plumb motion of 65 ° can be installed on the same shaft at different angles (6 5 2) by different control of the same crank element. Measurement section Figure 13 shows an embodiment of the measurement section 20. This is used to measure the brightness of the enzyme and the magnetic particles carrying antigen or antibody at a fixed wavelength. It includes a mirror 720, a partial mirror 721 and a photomultiplier 722. In this embodiment, the brightness at one time is measured by the photomultiplier 72 2 through the mirror 720 and the partial mirror 721, and the brightness at the next time is directly measured through the partial mirror 7 2 1. A rotator can be attached to remove errors due to abnormally reflected light, if necessary. Figure 14 shows another example of the measurement section. In FIG. 14, the first hole 4 c of the storage box 4 where the desired reaction will be measured is received in the upper opening of a light reflecting cylinder 730 in the form of a downward divergent hole, which is formed in In a block element 732, the block element 732 is provided on a hole formed in the first card day 734, and an upper circumference thereof is substantially the same as the hole 4c. An angle α of the tapered wall 736 of a cylinder 7300 may be in the range of 10 degrees to 60 degrees. Then, it has been found that a satisfactory result is obtained when the angle is 30 degrees. A second stack 7 3 8 is provided under the stack 7 34 to run parallel to each other. The second card stack 8 3 7 has a hole relative to, in position and size, the first tako language H Lingiij leisure Ψ due to K frame (21〇297) public interview-39-(please read the notes on the back first Fill in this page again) Binding-Stranding. 199858 A6 __B6_., 38 k button hole. A photomultiplier 740 is configured to borrow a suitable mechanism under the second stack 7 3 8 relative to the column 7 3 0. A filter 7 5 ◦ is arranged between the first card day and the second card β. The filter 7 5 0 includes a disc 7 5 2 that is rotatably supported by a pin 754 that supports these card stacks. The disc 752 has a plurality of holes 7 56 formed along a peripheral portion thereof, and a filter element 7 5 8 is arranged in each of the holes. The periphery of the disc is toothed to mesh with a gear 7 6 0 which is mounted on the horse 7 The axis of 6 2 is used to rotate the disc 7 5 2 by the motor 7 6 2 to place a desired filter element 7 5 6 just between the cylinder 7 3 0 and the photomultiplier 74◦. Figure 15 shows the relative positions of a disc 752, horse 762 and gear 7 6 ◦. Three filter elements 750 are provided in the illustrated embodiment, each having 1%, 10% and 100% light transmission. The number of filter elements and their light transmittance can be selected as required. Printed by the Employee Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs (please read the precautions on the back before filling out this page). A position sensor 7 7 0 is provided on the disc 7 5 2 to detect a rotation angle of the disc. The sensor 7 7 ◦can be a magnetic sensor. Based on an output of sensor 770, motor 764 is controlled to position a desired filter element in place. The tapered wall 736 of the cylinder 730 is important as described above. Figure 16 shows the results of experiments used to explain the effect of tapered cylinders. In this experiment, the brightness of the mixture of 0.1 mM tribuffer solution (pH 9.8), 2 ◦ microliters of age phosphatase (1 μg / ml) and 3 ◦ microliters of AMPPD D Cylindrical κ / i iS m Ψ ® ffi titafCNS'l Ψ4 »^ ί210 xZ97 ^ 一 4 · 0 _ 199858% Crab Leopard A 6 B 6 Ministry of Economic Affairs The bureau employees print cooperative shovel cartridge configurator. FIG. 17 is a plan view of the cartridge allocator and FIG. 18 is a perspective view of the cartridge allocator 21 shown in FIG. In Figs. 17 and 18, the cartridge allocator 21 is arranged at an end portion of the reaction line 11 where the cartridge is completely reached one by one for measurement. The configurator includes an arm raising device 926 which is mounted on the base 924. The lifting device 934 includes a pair of vertical rails 942, a vertical and slidable cam block 934 supported by the rails, a DC motor 922 has a shaft supporting a plate M938 is provided around it and contains a roller 9 4 0 and its A cam groove formed horizontally in the cam block 934 is engaged, a block 920 is firmly secured to the cam block 934 and the frame is covered with a stepping horse, an end of an arm 928 is fixedly connected to a shaft of the stepping motor and a pickup device 9 3 2 It is mounted on the other end of the arm 9 2 8. The pick-up device 92 has substantially the same structure as the pick-up device 33 like a magazine crane structure, and some parts are removed. In operation, the cam block 934 is raised along the track 942 via the disc 938 by the rotation of the horse 922, where the roller 94 engages the cam groove 936. Then, the stepping motor of block 92 is activated as a storage box to the end of the reaction line to drive the other end of the arm 9 2 8 and thus the pick-up device 932 is above the arriving storage box. After that, the cam block 9 34 is lowered onto the storage box so that the pick-up device 9 3 2 can hold the storage device in the same way as the pick-up device corresponding to the storage box lotus delivery mechanism (please read the precautions on the back side first) (This page is written) Gutter -41-19 ^^ 58 A 6 B6, 40, Printed by the Beigong Consumer Cooperative of the Bureau of Standards of the Ministry of Economic Affairs? The ink wheel block is raised again and the back 928 turns in the reverse direction. Above the configurator container 916. In this position, the pick-up device 932 is activated to release the magazine and allow it to fall into the container. This sequence of operations is repeated when each storage box arrives. Figures 19 to 22 each show a flowchart of the one-step method, two-step method, delay method, and two-step method with dilution, which are executed by the device. In these flowcharts, steps S1 and S2 are the same for all these methods. In step S1, an operator activates the start button 2a of the input section 2 so that the lotus input of the storage box in the storage box accumulator is initiated one by one to the starting position on the reaction line and stored and stored by the storage box crane The cassette lifting mechanism successively breaks the seal of the storage cassette on the reaction line via the seal breaker (step S2). The operator then operates its selection button 2b to select a response to a desired pattern. The central processing unit 24 outputs the selected program from the program recorder and starts the operation of controlling different parts of the device so that the selected program can be executed. In FIG. 19, which shows the above-mentioned one-step method, the sampling crane structure and the suction / dispensing inclined portion are activated to pick up a thin sheet in which the sample is taken into the first hole slot of the storage box by suction and dispensing, The contained magnetic particles carry antigens or antibodies, and after the sheet is configured, another sheet is picked up and the enzyme label contained in the second well of the storage cartridge is taken in and poured into the first well (step S3). Then, the first stirring portion 17a is activated to stir the mixture in the first orifice of the storage cartridge to move to the next position on the reaction line 70 (step S4). Then, when the storage box reaches a first magnetic unbound separator 18a, an unbound separator is executed, and then by (please read the precautions on the back before filling this page) too f! Φ ® ffi KiSmiCNS) Ψ4 Phase. 柊 ί: · Μ0χ297 (public goods) -42-19985 & A 6 B 6 Printed by the Ministry of Economic Affairs Central Standards Bureau Staff Consumers #Cooperative V. Invention description () One cleaning part 19a cleaning (step SI 1). Then, the bottom material is added to the first orifice by the bottom material pouring portion 16 c and stirred in the second stirring portion 17 b (step S 1 2). Then, a light measuring device performs the measurement part 20 (step S13) and an output thereof is supplied to the central processing unit 24 (step S14). At the same time, the storage box is configured by the configuration part (step S15). Figure 2◦ shows the above two-step method. After step S2, the sample is poured into the first hole of the storage box, which contains magnetic particles carrying the antigen or antibody (step S5). Then, the first stirring portion 17a is activated to stir the mixture in the first hole of the storage box to the next position on the reaction line 7 (step S6). Then, when the storage cartridge reaches the first magnetic unfettered separator 18a, the unfettered separator is executed, followed by cleaning by the first cleaning portion 19a (step S7). Then, the enzyme label contained in the second well of the storage cartridge is poured into the first well and stirred (step S 8). Thereafter, a magnetic unbound separation and cleaning is performed in step S9. Then, after stirring again in step S 1 ◦, the substrate is poured into the first hole tank from the substrate pouring portion 16c and stirred in the second stirring portion 17b (step S 1 2). Then, a light measurement is performed by the measuring section 20 (step S13) and an output thereof is supplied to the central processing unit 24 (step S14). At the same time, the storage box is configured with a borrowing and placing part (step S15). Fig. 21 shows the above-described method of using dilution to extend the steps in which steps S1 to S4 are the same as in Fig. 18. After step S4, the magnetic particles carrying the antigen or antibody contained in the first well of the storage box are mixed with the same sample and the enzyme (please read the precautions on the back before writing this page). Packing & Threading_ A 6 B6 199858 The compound is stirred and borrowed from the first mixing part (step S51). Then, steps S9 to S15 are executed correspondingly as shown in FIG. Figure 21 shows a two-step method using dilution. In FIG. 22, after step S2, the diluent is poured from the dilution portion 25 into the first hole of the storage box (step S61) and the sample is poured into the same hole (step S5). The resulting diluted sample is poured into a second well containing magnetic particles carrying antigen or antibody (step S62). Then, after stirring through the first stirring portion 17a (step S63), a non-binding separation and washing is performed in step S7. Thereafter, steps 8 to 15 in the same two-step method of FIG. 20 are executed. As described above, according to the present invention, the sequence of operations used to perform an immunoassay measurement can be completely automated by using storage cartridges each having at least two wells, at least one of which contains a solid phase material, and a A reaction line that moves the storage cassettes step by step through at least one unbound separator, at least one stirrer, at least one pouring part, at least one cleaning part, and a light measuring part when performing operations related to the storage case, And so on, arranged in the proper order along the reaction line. The above-mentioned storage boxes can be individually modified to suit the desired application. The components of this device can also be modified appropriately. Such correction is also included in the scope of the present invention. (Please read the precautions on the back before writing this page) Pack-line. Printed by the Staff Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs *** 44-